External fixation versus conservative treatment for distal

Transcription

radial fractures in adults (Review)
Handoll HHG, Huntley JS, Madhok R
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2008, Issue 4
http://www.thecochranelibrary.com
External fixation versus conservative treatment for distal radial fractures in adults (Review)
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ACKNOWLEDGEMENTS
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REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.1. Comparison 1 External fixation versus plaster cast, Outcome 1 Functional grading: not excellent. . .
Analysis 1.2. Comparison 1 External fixation versus plaster cast, Outcome 2 Functional grading: not excellent. Worst and
best case scenarios sensitivity analyses. . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.3. Comparison 1 External fixation versus plaster cast, Outcome 3 Functional grading: fair or poor. . . .
Analysis 1.4. Comparison 1 External fixation versus plaster cast, Outcome 4 Subjective and objective functional
evaluation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.5. Comparison 1 External fixation versus plaster cast, Outcome 5 Upper extremity function part of
Musculoskeletal Function Assessment tool (0 to 100: maximum disability).
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Analysis 1.6. Comparison 1 External fixation versus plaster cast, Outcome 6 Difficulties in activities of daily living. .
Analysis 1.7. Comparison 1 External fixation versus plaster cast, Outcome 7 Job change because of injury. . . . .
Analysis 1.8. Comparison 1 External fixation versus plaster cast, Outcome 8 Mass grip strength (% of normal side). .
Analysis 1.9. Comparison 1 External fixation versus plaster cast, Outcome 9 Grip, chuck and pinch strengths (injured normal side): units not given. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.10. Comparison 1 External fixation versus plaster cast, Outcome 10 Maximal voluntary contraction: injured uninjured side (Newtons). . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.11. Comparison 1 External fixation versus plaster cast, Outcome 11 Persistent pain (1 year & 7 years). . .
Analysis 1.12. Comparison 1 External fixation versus plaster cast, Outcome 12 Pain (6 months). . . . . . . .
Analysis 1.13. Comparison 1 External fixation versus plaster cast, Outcome 13 Range of movement at 1 year (% of normal
side). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.14. Comparison 1 External fixation versus plaster cast, Outcome 14 Range of movement at 2 years (injured normal side). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.15. Comparison 1 External fixation versus plaster cast, Outcome 15 Range of movement at 1 year. . . .
Analysis 1.16. Comparison 1 External fixation versus plaster cast, Outcome 16 Range of movement at 7 years. . . .
Analysis 1.17. Comparison 1 External fixation versus plaster cast, Outcome 17 Complications. . . . . . . . .
Analysis 1.18. Comparison 1 External fixation versus plaster cast, Outcome 18 Reflex sympathetic dystrophy - exploratory
analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.19. Comparison 1 External fixation versus plaster cast, Outcome 19 Cosmetic deformity. . . . . . .
Analysis 1.20. Comparison 1 External fixation versus plaster cast, Outcome 20 Patient dissatisfied with wrist. . . .
Analysis 1.21. Comparison 1 External fixation versus plaster cast, Outcome 21 Anatomical grading: not excellent. .
Analysis 1.22. Comparison 1 External fixation versus plaster cast, Outcome 22 Anatomical grading: fair or poor. . .
Analysis 1.23. Comparison 1 External fixation versus plaster cast, Outcome 23 Anatomical displacement. . . . .
Analysis 1.24. Comparison 1 External fixation versus plaster cast, Outcome 24 Anatomical measurements. . . . .
Analysis 1.25. Comparison 1 External fixation versus plaster cast, Outcome 25 Structural deformity. . . . . . .
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
FEEDBACK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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DECLARATIONS OF INTEREST
SOURCES OF SUPPORT . . .
NOTES . . . . . . . . . .
INDEX TERMS
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[Intervention Review]
radial fractures in adults
Helen HG Handoll1 , James S Huntley2 , Rajan Madhok3
1 Centre
for Rehabilitation Sciences (CRS), Research Institute for Health Sciences and Social Care, University of Teesside, Middlesborough, UK. 2 University Department of Orthopaedic Surgery, Royal Infirmary of Edinburgh, Edinburgh, UK. 3 Cochrane Bone, Joint
and Muscle Trauma Group, University of Manchester, Manchester, UK
Contact address: Helen HG Handoll, Centre for Rehabilitation Sciences (CRS), Research Institute for Health Sciences and Social
Care, University of Teesside, School of Health and Social Care, Middlesborough, Tees Valley, TS1 3BA, UK. [email protected].
[email protected].
Editorial group: Cochrane Bone, Joint and Muscle Trauma Group.
Publication status and date: Edited (no change to conclusions), published in Issue 4, 2008.
Review content assessed as up-to-date: 16 May 2007.
Citation: Handoll HHG, Huntley JS, Madhok R. External fixation versus conservative treatment for distal radial fractures in adults.
Cochrane Database of Systematic Reviews 2007, Issue 3. Art. No.: CD006194. DOI: 10.1002/14651858.CD006194.pub2.
ABSTRACT
Background
Fracture of the distal radius (’broken wrist’) is a common clinical problem. It can be treated conservatively, usually involving wrist
immobilisation in a plaster cast, or surgically. A key method of surgical fixation is external fixation.
Objectives
To evaluate the evidence from randomised controlled trials comparing external fixation with conservative treatment for fractures of the
distal radius in adults.
Search strategy
We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (September 2006), the Cochrane Central
Register of Controlled Trials, MEDLINE, EMBASE and other databases, conference proceedings and reference lists of articles. No
language restrictions were applied.
Selection criteria
Randomised or quasi-randomised controlled clinical trials involving adults with a fracture of the distal radius, which compared external
fixation with conservative treatment.
Data collection and analysis
After independent study selection by all review authors, two authors independently assessed the included trials. Independent data
extraction of new trials was performed by two authors. Pooling of data was undertaken where appropriate.
Main results
Fifteen heterogeneous trials, involving 1022 adults with dorsally displaced and potentially or evidently unstable distal radial fractures,
were included. While all trials compared external fixation versus plaster cast immobilisation, there was considerable variation especially in
1
terms of patient characteristics and interventions. Methodological weaknesses among these trials included lack of allocation concealment
and inadequate outcome assessment.
External fixation maintained reduced fracture positions (redisplacement requiring secondary treatment: 7/356 versus 51/338 (data
from 9 trials); relative risk 0.17, 95% confidence interval 0.09 to 0.32) and prevented late collapse and malunion compared with plaster
cast immobilisation. There was insufficient evidence to confirm a superior overall functional or clinical result for the external fixation
group. External fixation was associated with a high number of complications, such as pin-track infection, but many of these were minor.
Probably, some complications could have been avoided using a different surgical technique for pin insertion. There was insufficient
evidence to establish a difference between the two groups in serious complications such as reflex sympathetic dystropy: 25/384 versus
17/347 (data from 11 trials); relative risk 1.31, 95% confidence interval 0.74 to 2.32.
Authors’ conclusions
There is some evidence to support the use of external fixation for dorsally displaced fractures of the distal radius in adults. Though there
is insufficient evidence to confirm a better functional outcome, external fixation reduces redisplacement, gives improved anatomical
results and most of the excess surgically-related complications are minor.
PLAIN LANGUAGE SUMMARY
External fixation versus conservative treatment for distal radial fractures in adults
In older people, a ’broken wrist’ (from a fracture at the lower end of one of the two forearm bones) can result from a fall onto an
outstretched hand. Treatment usually involves reduction (putting the broken bone back into position) and immobilising the wrist in a
plaster cast (conservative treatment). Surgery may be considered for more seriously displaced fractures. One type of surgery is external
fixation, in which metal pins are driven into bone, generally via small skin incisions, on either side of the fracture. These pins are then
fixed externally by incorporation into a plaster cast or securing into the frame of an external fixator. The external component holds
the bony fragments in position while the bone heals. This review looked at the evidence from randomised controlled trials comparing
external fixation with conservative treatment.
Fifteen trials, involving 1022 adults with potentially or evidently unstable fractures, were included. While all trials compared external
fixation versus plaster cast immobilisation, there was considerable variation in their characteristics especially in terms of patient
characteristics and the method of external fixation. Weak methodology, such as using inadequate methods of randomisation and
outcome assessment, means that the possibility of serious bias can not be excluded.
The review found that external fixation reduced fracture redisplacement that prompted further treatment and generally improved final
anatomical outcome. It appears to improve function too but this needs to be confirmed. The complications, such a pin tract infection,
associated with external fixation were many but were generally minor. Serious complications occurred in both groups. The review
concludes that there is some evidence to support the use of external fixation for these fractures.
BACKGROUND
Note: This is one of five reviews that will cover all surgical interventions for treating distal radial fractures in adults. Each review
will provide updated evidence for one of the several surgical categories that are presented together in the currently available review (Handoll 2003a). Following publication of the five reviews,
Handoll 2003a will be converted to an ’umbrella’ review summarising the evidence for surgical treatment for these fractures.
Description of the condition: distal radial fracture in adults
Fractures of the distal radius, often referred to as “wrist fractures”,
are common in both children and adults. They are usually defined
as occurring in the distal radius within three centimetres of the
radiocarpal joint, where the lower end of the radius interfaces with
two (the lunate and the scaphoid) of the eight bones forming the
carpus (the wrist). The majority are closed injuries, the overlying
skin remaining intact.
In this review, we consider the treatment of distal radial fracture in
adults only, in whom they are one of the most common fractures,
predominantly in white and older populations in the developed
world (Sahlin 1990; Singer 1998; Van Staa 2001). In women, the
2
incidence of these fractures increases with age, starting at around
40 years. Before this age, the incidence is higher in men (Singer
1998). In contrast, between 60 to 94 years of age, females predominate. A recent multi-centre study in the United Kingdom of
patients aged 35 years and above with Colles’ fracture (see below)
reported an annual incidence of 9/10,000 in men and 37/10,000
in women (O’Neill 2001).
Young adults usually sustain this injury as a result of high-energy
trauma, such as a traffic accident. In older adults, especially females, the fracture more often results from low-energy or moderate trauma, such as falling from standing height. This reflects
the greater fragility of the bone, resulting from osteoporosis. It
has been estimated that, at 50 years of age, a white woman in the
USA or Northern Europe has a 15% lifetime risk of a distal radius
fracture whereas a man has a lifetime risk of just over two per cent
(Cummings 1985). More recent estimates (Van Staa 2001) of lifetime risk of radius or ulna fracture at 50 years of age are similar:
16.6% for women versus 2.9% for men.
Distal radial fractures are usually treated on an outpatient basis.
It is estimated that around 20% of patients (mainly older people)
require hospital admission (Cummings 1985; O’Neill 2001). This
figure includes all people receiving surgery.
Classification
Surgeons have classified fractures by anatomical configuration and
fracture pattern, to help in their management. Simple classifications were based on clinical appearance and often named after
those who described them. In the distal radius, the term “Colles’
fracture” is still used for a fracture in which there is an obvious
and typical clinical deformity (commonly referred to as a ’dinner
fork deformity’) - dorsal displacement, dorsal angulation, dorsal
comminution (fragmentation), and radial shortening. The introduction of X-rays and other imaging methods made it clear that
the characteristic deformity may be associated with a range of different fracture patterns, which may be important determinants
of outcome, and therefore the way in which treatment is conducted. For example, the fracture through the distal radius may
be extra-articular (leaving the articular surface of the radius intact)
or intra-articular (the articular surface is disrupted, sometimes in
a complex manner). Numerous classifications have been devised
to define and group different fracture patterns (Chitnavis 1999).
One of the most commonly used is that of Frykman which distinguishes between extra-articular fractures and intra-articular fractures of the radiocarpal and radio-ulnar joints, and the presence
or absence of an associated distal ulnar (ulnar styloid) fracture (
Frykman 1967). Another commonly used system is the AO (Arbeitsgemeinschaft fur Osteosynthesefragen) system (Muller 1991)
which divides the fractures into three major groups: group A (extra-articular), group B (simple/partial intra-articular), and group
C (complex/complete intra-articular). These three groups are then
subdivided, yielding 27 different fracture types. Other classifica-
tion systems have attempted to link fracture type more directly
with fracture management. For instance, Cooney 1993 proposed a
’Universal Classification’ based on fracture displacement, articular
involvement, reducibility (whether the fracture can be reduced;
that is whether the bone fragments can be put back in place) and
stability (whether, once reduced, the fragments will remain so).
Description of the intervention: external fixation
In the last century, most distal radial fractures in adults were treated
conservatively, by reduction of the fracture when displaced, and
stabilisation in a plaster cast or other external brace. The results of
such treatment, particularly in older people with bones weakened
by osteoporosis, are not consistently satisfactory (Handoll 2003b).
This has resulted in attempts to develop other strategies involving
surgery aimed at more accurate reduction and more reliable stabilisation.
One such strategy is external fixation (Capo 2006; Fernandez
1999; Pennig 1996). Typically this is a closed, minimally invasive
method where, in contrast to open surgery, the fractured bone ends
are not exposed to direct view. Metal pins or screws are driven into
bone, generally via small incisions of the skin and after drilling,
on either side of the fracture. These pins are then fixed externally,
such as by incorporation into a plaster cast or securing into an
external fixator frame. The external component stabilises or ’fixes’
the reduced fracture. Fracture reduction or alignment of the bony
fragments is generally achieved by closed means, often in the process of applying external fixation. Reduction may be assisted by
the application of a percutaneously (through the skin) inserted
wire as a ’joy stick’ to move the bony fragments back into place.
There is considerable variety in the techniques (such as for pin
insertion and placement) and devices used for external fixation.
Some devices are ’non-bridging’ (of the wrist joint) in that the
distal pins are placed in the distal radial fragment. In ’bridging fixators’, the distal pins are placed in one or more metacarpal bones.
Some fixators are linear or uniplanar, whereas others are multiplanar. In addition, some bridging fixators have an articulation (e.g. a
ball joint) that allows limited wrist movement. The duration and
extent of immobilisation with external fixation also vary. In some
cases, external fixation may be augmented by additional methods
of fracture fixation. In this review, we include only trials using
supplementary percutaneous pinning. This involves extra pins or
wires being inserted through the skin and used to fix or support
distal radial fragments.
Complications
Complications from this injury are diverse and frequent (Altissimi
1986; Atkins 1989; Cooney 1980). Some are associated with the
injury itself. As well as concomitant injuries to soft tissues, fracture
displacement can further compromise blood vessels, tendons and
nerves, with median nerve dysfunction being the most common
complication (Belsole 1993). Late complications include mid-
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carpal instability and post-traumatic arthritis which can occur several months or years after injury (Knirk 1986; Taleisnik 1984).
Complications can also result from treatment interventions and
include residual finger stiffness, which may be due to faulty application of plaster casts (Gartland 1951), pin track infection,
soft tissue injury including tendon rupture, and additional fractures. Complex regional pain syndrome type 1, often termed reflex
sympathetic dystrophy (RSD), but also referred to as algodystrophy, Sudeck’s atrophy and sometimes shoulder-hand syndrome (
Fernandez 1996) is a major complication (Atkins 2003) requiring
many months of physiotherapy to alleviate symptoms (pain and
tenderness, impairment of joint mobility, swelling, dystrophy, vasomotor instability) in serious cases. The pathology of RSD remains unclear.
Why it is important to do this review
External fixation is one of the main methods for surgical fixation
of distal radial fractures. A key question is whether it produces
superior results, particularly in terms of function, to conservative
treatment. The answer to this question is likely to depend particularly on fracture configuration and bone quality. The issue of
what is the best method of external fixation will be addressed in a
separate review (Handoll 2007).
Types of studies
Any randomised or quasi-randomised (method of allocating participants to a treatment which is not strictly random e.g. by date
of birth, hospital record number, alternation) controlled clinical
trial comparing external fixation with conservative methods for
treating distal radial fractures in adults was considered.
Types of participants
Included were patients of either sex who have completed skeletal
growth, with a fracture of the distal radius. External fixation may
be considered as primary treatment or take place after the failure
of initial conservative management, generally within two to three
weeks. Augmented external fixation in the form of supplementary
percutaneous pinning was also included. Trials with a mixed population of adults and children were included provided the proportion of children was clearly small (< 5%); otherwise they would
have been excluded unless separate data for adults were obtained.
We considered it unlikely that we would find trials comparing external fixation with conservative treatment for rarer fracture patterns such as the Barton’s fractures (Smith 1988) that are inherently unstable and generally considered not to be amenable to
conservative or external fixation. Nonetheless, if found, trials with
these types of fractures would have been considered for inclusion,
and separate subgroup data sought for mixed fracture populations.
OBJECTIVES
We aimed to evaluate the evidence from randomised controlled
trials for the use of external fixation for fractures of the distal radius
in skeletally mature people.
We compared the relative effects (benefits and harms) of any
method of external fixation versus conservative treatment involving plaster or brace use in adults with these injuries. Also considered was augmented external fixation where supplementary percutaneous (through the skin) pinning was used to fix or support
distal radial fragments.
We considered these effects primarily in terms of patient-assessed
functional outcome and satisfaction, and other measures of function and impairment, pain and discomfort, the incidence of complications, anatomical deformity and use of resources.
Our plan to study the outcomes in different age groups and for
different fracture types, especially whether they are extra-articular
or intra-articular, was thwarted by the variation in the trial characteristics.
METHODS
Criteria for considering studies for this review
Types of interventions
Randomised comparisons of surgical interventions involving external fixation by itself or with supplementary percutaneous pinning versus conservative interventions such as plaster cast immobilisation.
We excluded trials comparing different methods, including techniques and devices, of external fixation; or trials comparing external fixation with other methods of surgical fixation, such as percutaneous pinning, or trials evaluating the use of supplementary
methods, such as bone grafts and substitutes, other than percutaneous pinning, to external fixation compared with conservative
treatment. These comparisons will be covered in other reviews,
including one covering the use of bone grafts and substitutes.
Types of outcome measures
Our primary outcome of choice would be the number of people
with an uncomplicated and speedy restoration of a pain-free fullyfunctioning wrist and arm with acceptable anatomic restoration
and appearance. However, compatible with the general assessment
and presentation of outcome within the orthopaedic literature, we
report outcome in the following four categories.
Primary outcomes
(1) Functional outcome and impairment
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• Patient functional assessment instruments such as Short
Form-36 (SF-36), the Disability of the Arm, Shoulder, and
Hand questionnaire (DASH) and the Patient-Rated Wrist
Evaluation (PRWE) (MacDermid 2000)
• Return to previous occupation, including work, and
activities of daily living
• Grip strength
• Pain
• Range of movement (wrist and forearm mobility): range of
movement for the wrist is described in terms of six parameters:
flexion (ability to bend the wrist downwards) and extension (or
upwards); radial deviation (ability to bend the wrist sideways on
the thumb side) and ulnar deviation (on the little finger side);
and pronation (ability to turn the hand so that the palm faces
downwards) and supination (palm faces upwards)
(2) Clinical outcome
• Residual soft tissue swelling
• Early and late complications associated with distal radial
fractures or their treatment, including reflex sympathetic
dystrophy (RSD) and post traumatic osteoarthritis
• Cosmetic appearance
• Patient satisfaction with treatment
Secondary outcomes
(3) Anatomical outcome (anatomical restoration and residual
deformity)
• Radiological parameters include radial length or shortening
and shift, dorsal angulation, radial inclination or angle, ulnar
variance, and for intra-articular fractures: step off and gap
deformity of the articular surface (Fernandez 1996; Kreder
1996a). Composite measures include malunion and total
radiological deformity. Definitions of four of the most commonly
reported radiological parameters are presented in Table 1.
Table 1. Definitions of key radiological parameters
Parameter
Definition
Normal value
Dorsal angulation (dorsal or volar or pal- Angle between a) the line which connects Palmar or volar tilt: approximately 11-12
mar tilt)
the most distal points of the dorsal and degrees.
volar cortical rims of the radius and b) the
line drawn perpendicular to the longitudinal axis of the radius. Side view of wrist.
Radial length
Distance between a) a line drawn at the tip Approximately 11-12 mm.
of the radial styloid process, perpendicular
to the longitudinal axis of the radius and
b) a second perpendicular line at the level
of the distal articular surface of the ulnar
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Table 1. Definitions of key radiological parameters
(Continued)
head. Frontal view.
Radial angle or radial inclination
Angle between a) the line drawn from the Approximately 22-23 degrees.
tip of the radial styloid process to the ulnar
corner of the articular surface of the distal
end of the radius and b) the line drawn
perpendicular to the longitudinal axis of
the radius. Frontal view.
Ulnar variance
Vertical distance between a) a line drawn Usually negative variance (e.g. -1 mm) or
parallel to the proximal surface of the lu- neutral variance.
nate facet of the distal radius and b) a line
parallel to the articular surface of the ulnar
head.
(4) Resource use
We also searched Current Controlled Trials at www.controlledtrials.com (accessed September 2006) and the UK National Research Register at www.update-software.com/national/ (up to Issue 3, 2006) for ongoing and recently completed trials.
• Hospital stay, number of outpatient attendances and other
costs.
Timing of outcome assessment
Searching other resources
Results were usually collected for the final follow-up time for which
these are available. However, we also noted interim results where
a marked and important difference in the timing of recovery had
occurred.
We searched the reference list of articles. We also included the
findings from handsearches of the British Volume of the Journal of
Bone and Joint Surgery supplements (1996 onwards) and abstracts
of the American Society for Surgery of the Hand annual meetings (2000 to 2006: www.assh.org/), the American Orthopaedic
Trauma Association annual meetings (1996 to 2005: http://
www.hwbf.org/ota/am/) and American Academy of Orthopaedic
Surgeons annual meeting (2004 to 2006: http://www.aaos.org/
education/anmeet/libscip.asp). We also included handsearch results from the final programmes of SICOT (1996 & 1999) and
SICOT/SIROT (2003), and the British Orthopaedic Association
Congress (2000, 2001, 2002 and 2003), and various issues of Orthopaedic Transactions and Acta Orthopaedica Scandinavica Supplementum.
We also scrutinised weekly downloads of “Fracture” articles in new
issues of 17 journals (Acta Orthop Scand; Am J Orthop; Arch
Orthop Trauma Surg; Clin J Sport Med; Clin Orthop; Emerg Med
Clin North Am; Foot Ankle Int; Injury; J Accid Emerg Med; J Am
Acad Orthop Surg; J Arthroplasty; J Bone Joint Surg Am; J Bone
Joint Surg Br; J Foot Ankle Surg; J Orthop Trauma; J Trauma;
Orthopedics) from AMEDEO (www.amedeo.com).
Search methods for identification of studies
Electronic searches
We searched the Cochrane Bone, Joint and Muscle Trauma Group
Specialised Register (September 2006), the Cochrane Central Register of Controlled Trials (in The Cochrane Library 2006, Issue 3)
(see Appendix 1), MEDLINE (1966 to September week 1 2006),
EMBASE (1988 to 2006 week 36), CINAHL (1982 to September
week 2 2006). No language restrictions were applied.
In MEDLINE (OVID-WEB) the search strategy was combined
with all three sections of the optimal MEDLINE search strategy
for randomised trials (Higgins 2005) (see Appendix 2).
Similar search strategies were used for EMBASE (OVID-WEB)
and CINAHL (OVID-WEB) (see Appendix 3).
6
Data collection and analysis
Selection of studies
All review authors independently assessed potentially eligible trials for inclusion using a pre-piloted form. Any disagreement was
resolved by discussion.
Data extraction and management
Using a data extraction form, two of the review authors (HH and
JH) independently extracted trial details and data for new trials,
and one author (HH) repeated data extraction of trials already
included in Handoll 2003a and checked for consistency with her
previous data extraction. HH entered the data into RevMan. Any
disagreements were resolved by discussion. When appropriate, extraction of results from graphs in trial reports was performed where
data were not provided in the text or tables. We contacted trialists
of trials not reported in full journal publications for additional
information or data. Contact with other trial authors was dictated
by the vintage of the publication, a general impression of the expected gain, and anticipated or known difficulty in locating trial
authors.
Results were collected for the final follow-up time for which these
were available. We also noted instances where clinically important
differences had been reported at intermediate follow-up assessments.
Assessment of methodological quality
In this review, risk of bias is implicitly assessed in terms of methodological quality.
Two of the review authors (HH and JH) independently assessed
methodological quality of the newly included trials using a prepiloted form. One author (HH) repeated her assessment of the
trials already included in Handoll 2003a. All disagreements were
resolved by discussion. Titles of journals, names of authors or supporting institutions were not masked at any stage. A modification
of the quality assessment tool used in the current ’umbrella’ review was used. Instead of scores, each item was graded based on
whether the quality criterion was met: ’Y’ (met), ’?’ (possibly or
only partially met) or ’N’ (not met). The rating scheme covering
11 aspects of trial validity plus brief notes of coding guidelines for
selected items are given in Table 2.
Table 2. Methodological quality assessment scheme
Items
Scores
Notes
(1) Was the assigned treatment adequately Y = method did not allow disclosure of as- Cochrane code (see Handbook): Clearly
concealed prior to allocation?
signment.
yes = A; Not sure = B; Clearly no = C.
? = small but possible chance of disclosure
of assignment or unclear.
N = quasi-randomised, or open list or tables.
7
(Continued)
(2) Were the outcomes of participants who Y = withdrawals well described and acwithdrew described and included in the counted for in analysis.
analysis (intention-to-treat)?
? = withdrawals described and analysis not
possible, or probably no withdrawals.
N = no mention, inadequate mention, or
obvious differences and no adjustment.
(3) Were the outcome assessors blinded to Y = effective action taken to blind assessors.
treatment status?
? = small or moderate chance of unblinding
of assessors, or some blinding of outcomes
attempted.
N = not mentioned or not possible.
(4) Were important baseline characteristics Y = good comparability of groups, or conreported and comparable?
founding adjusted for in analysis.
? = confounding small, mentioned but not
adjusted for, or comparability reported in
text without confirmatory data.
N = large potential for confounding, or not
discussed.
Although many characteristics including
hand dominance are important, the principal confounders are considered to be age,
gender, type of fracture.
(5) Were the trial participants blind to as- Y = effective action taken to blind particisignment status after allocation?
pants.
of participants.
N = not possible, or not mentioned (unless
double-blind), or possible but not done.
(6) Were the treatment providers blind to Y = effective action taken to blind treatment
assignment status?
providers.
of treatment providers.
N = not possible, or not mentioned (unless
double-blind), or possible but not done.
(7) Were care programmes, other than the Y = care programmes clearly identical.
trial options, identical?
? = clear but trivial differences, or some evidence of comparability.
N = not mentioned or clear and important
differences in care programmes.
Examples of clinically important differences in other interventions are: time of intervention, duration of intervention, anaesthetic used within broad categories, operator experience, difference in rehabilitation.
(8) Were the inclusion and exclusion crite- Y = clearly defined (including type of fracria for entry clearly defined?
ture).
? = inadequately defined.
N = not defined.
(9) Were the outcome measures used clearly Y = clearly defined.
defined?
? = inadequately defined.
N = not defined.
8
(Continued)
(10) Were the accuracy and precision, Y = optimal.
with consideration of observer variation, of ? = adequate.
the outcome measures adequate; and were N = not defined, not adequate.
these clinically useful and did they include
active follow up?
(11) Was the timing (e.g. duration of Y = optimal. (> 1 year)
surveillance) clinically appropriate?
? = adequate. (6 months - 1 year)
N = not defined, not adequate. (< 6
months)
Measures of treatment effect
Where available, quantitative data, both dichotomous and continuous, for the outcome measures listed above (see ’Types of outcome
measures’) are presented in the analyses. Relative risks and 95%
confidence intervals were calculated for dichotomous outcomes
and mean differences and 95% confidence intervals calculated for
continuous outcomes.
Unit of analysis issues
No unit of analysis issues arose in this review.
Dealing with missing data
Where appropriate, we have performed intention-to-treat analyses
to include all people randomised to the intervention groups. To
a limited extent, we have investigated the effect of drop outs and
exclusions by conducting worse and best scenario analyses. We
were alert to the potential mislabeling or non identification of
standard errors for standard deviations. Unless missing standard
deviations could be derived from confidence interval data, we did
not assume values in order to present these in the analyses.
Assessment of heterogeneity
Heterogeneity was assessed by visual inspection of the forest plot
(analysis) along with consideration of the test for heterogeneity
and the I² statistic (Higgins 2003).
When considered appropriate, results of comparable groups of
trials were pooled. Initially we used the fixed-effect model and 95%
confidence intervals. We also considered using the random-effects
model, especially where there was unexplained heterogeneity.
Subgroup analysis and investigation of heterogeneity
There were no data available to carry out our pre-specified subgroup analyses by age, gender and type of fracture (primarily, extraarticular versus intra-articular fractures). Presentation in separate
subgroups was also considered where there was a fundamental difference in the method of external fixation (such as bridging versus
non-bridging external fixation; the use of supplementary percutaneous pinning), but considered inappropriate. To test whether the
subgroups are statistically significantly different from one another,
we tested the interaction using the technique outlined by Altman
and Bland (Altman 2003).
Sensitivity analysis
There were no data available to carry out our pre-specified sensitivity analyses examining various aspects of trial and review methodology, including the study quality (specifically allocation concealment, outcome assessor blinding and reportage of surgical experience).
Interpretation of the evidence
Assessment of reporting biases
There were insufficient data to assess publication bias; for example,
by preparing a funnel plot.
Data synthesis (meta-analysis)
We graded the findings of the treatment comparison(s) according
to the six categories of effectiveness used by contributors to Clinical
Evidence (BMJ 2006) (see Table 3) to assist our interpretation of
the evidence.
Table 3. Categories of effectiveness (definitions)
Rank
Category
Definition
9
Table 3. Categories of effectiveness (definitions)
(Continued)
1
Beneficial
Interventions for which effectiveness has been demonstrated by clear evidence from
randomised controlled trials, and for which expectation of harms is small compared
with the benefits.
2
Likely to be beneficial
Interventions for which effectiveness is less well established than for those listed
under “beneficial”.
3
Trade off between benefits and harms
Interventions for which clinicians and patients should weigh up the beneficial and
harmful effects according to individual circumstances and priorities.
4
Unknown effectiveness
Interventions for which there is currently insufficient data or data of inadequate
quality.
5
Unlikely to be beneficial
Interventions for which lack of effectiveness is less well established than for those
listed under “likely to be ineffective or harmful”
6
Likely to be ineffective or harmful
Interventions for which ineffectiveness or harmfulness has been demonstrated by
clear evidence.
RESULTS
Description of studies
See: Characteristics of included studies; Characteristics of excluded
studies.
Results of the search
The search for trials predated the development of this review,
which is essentially a reworked update of part of a previously published review (Handoll 2003a) covering all surgical intervention
for these fractures. We have not documented the numbers of references retrieved by electronic searches; updates of MEDLINE,
EMBASE and CINAHL are now generated on a weekly basis. Of
21 potentially eligible studies put forward for study selection, 15
were included, five were excluded and one is in ’Studies awaiting
assessment’.
Twelve of the included trials were previously included in Handoll
2003a; this includes Young 2003, whose study ID has been
changed to reflect the identification of a full report. The three additional trials (Hegeman 2004; Kreder 2006; Zheng 2003) have
been included in the current review; the Kreder trial was listed as
ongoing in Handoll 2003a.
Included studies
All of the included studies were fully reported in medical journals.
Six of the included trials were initially located by handsearching.
The rest were located in the following ways: The Cochrane Bone,
Joint and Muscle Trauma Group Specialist Register (2); MEDLINE (5); PubMed (1) and bibliography checking (1). A translation from Chinese was obtained for Zheng 2003.
Details of the methods, participants, interventions and outcome
measures of individual trials are provided in the ’Characteristics
of included studies’ table.
Setting
The publication dates of the main reports of these trials span 18
years; Pring 1988 being the earliest. Each trial took place in one
of nine countries: Canada (1 trial), China (1), India (1), Israel (1),
New Zealand (1), Spain (1), Sweden (2), The Netherlands (2), and
the UK (5). All were all single-centre studies apart from Kreder
2006, which had three centres. Most were conducted in teaching
hospitals.
Participants
Age and gender
The 15 included trials involved a total of 1022 participants. Five
trials (Horne 1990; Howard 1989; Jenkins 1989; Roumen 1991;
Stein 1990) provided no information on the gender composition
of their study populations. For the rest, the percentage of females
ranged from 17% (Rodriguez-Merchan 92) to 91% (Hegeman
2004). The mean ages of the trial populations ranged from 36
years (Rodriguez-Merchan 92) to 72 years (Horne 1990). Aside
10
from restricting trial participation to people over 55 years, Roumen
1991 provided no information on age. Only the age range (18 to
52 years) of the study population was provided for Zheng 2003. It
is clear that the vast majority of participants in the included trials
were skeletally mature: in particular, three trials (Kapoor 2000;
Kreder 2006; Young 2003) excluded children either by explicitly setting a minimum age limit or stipulating that the participants should be adult or skeletally mature. Four trials (Hegeman
2004; Horne 1990; Lagerstrom 1999; Roumen 1991) further restricted the trial population to more mature adults: above 55, 60,
45 and 55 years respectively. Upper age limits were applied in eight
trials (Abbaszadegan 1990: 75 years; Hegeman 2004: 80 years;
Howard 1989: 75 years; Jenkins 1989: 65 years; Kreder 2006:
75 years; Lagerstrom 1999: 75 years; Rodriguez-Merchan 92: 45
years; Young 2003: 75 years).
Overall the trials in terms of age and gender of their study populations appear to fall into three categories:
• Four trials (Jenkins 1989; Kapoor 2000; RodriguezMerchan 92; Zheng 2003) had predominantly younger adult
populations. There were more males than females in three of
these trials; no data on gender mix were provided for Jenkins
1989.
• Seven trials (Abbaszadegan 1990; Howard 1989; Kreder
2006; McQueen 1996; Pring 1988; Stein 1990; Young 2003)
included a general adult population, albeit some with an upper
age limit (generally 75 years). The majority of participants were
women in five of these trials; no data on gender mix were
provided for Howard 1989 and Stein 1990.
• Four trials (Hegeman 2004; Horne 1990; Lagerstrom
1999; Roumen 1991) restricted their population to older people.
The majority of participants in three of these trials were women;
no data on gender mix were provided for Horne 1990.
Types of fractures
Two trials (McQueen 1996; Roumen 1991) recruited people
whose fractures had redisplaced by two weeks, whereas the other
13 trials involved primary treatment of people with acute fractures. No trial referred to people with open fractures and it is likely
that all fractures were closed; this was explicit in Kreder 2006 and
Zheng 2003.
Several descriptions were used to define the types of fracture in
the included trials. Fourteen trials gave explicit reference to the
inclusion of dorsally displaced or Colles’ fractures (including the
use of Older’s classification: Older 1965) or presented radiological
results indicating that fractures were dorsally displaced. Kapoor
2000 included both dorsally and volarly displaced intra-articu-
lar fractures. Six trials (Horne 1990; Jenkins 1989; Kapoor 2000;
Pring 1988; Rodriguez-Merchan 92; Zheng 2003) provided no
criteria of the extent of the displacement required for trial entry.
Kreder 2006 set an upper limit of the extent of dorsal angulation
and metaphyseal comminution as well as stipulating joint congruity; this reflected the inclusion criteria of another concurrent
trial involving more displaced fractures (Kreder 2005). Only intra-articular fractures were included in six trials (Hegeman 2004;
Kapoor 2000; Lagerstrom 1999; Rodriguez-Merchan 92; Roumen
1991; Stein 1990). Both intra-articular and extra-articular fractures were clearly included in the remaining trials except Howard
1989; however, some, if not most, of the severely displaced and
comminuted Colles’ fractures of this trial were intra-articular. Of
the 13 trials applying or reporting fracture type according to an established classification system, two trials grouped fractures according to more than one classification system. Seven trials referred to
the Frykman system, four trials to the AO system and two trials
to Older’s system. Zheng 2003 categorised their fractures according to the universal system (Cooney 1993), which also includes
whether the fractures were reducible.
Interventions
All 15 trials compared external fixation with plaster cast immobilisation. There was, however, considerable variety in the devices
used for external fixation and in surgical techniques such as methods of reduction, pin insertion and pin placement. The duration
and extent of immobilisation in both the external fixation and
conservative treatment groups also varied among trials. One trial (
Pring 1988) used pins incorporated into plaster. One trial (Jenkins
1989) applied a (multiplanar) fixator that did not bridge the wrist
joint. Linear or uniplanar fixators which bridged the wrist joint
were clearly used in eight trials (Abbaszadegan 1990; Horne 1990;
Lagerstrom 1999; McQueen 1996; Rodriguez-Merchan 92; Stein
1990; Young 2003; Zheng 2003) and non-linear or multi-planar
fixators used in three trials (Howard 1989; Kapoor 2000; Roumen
1991). The configurations of the external fixator frames used in
Hegeman 2004 and Kreder 2006 were not clear, but were probably uniplanar. Explicit use of optional percutaneous K-wire fixation to stabilise the fracture was referred to in three trials (Kreder
2006; Rodriguez-Merchan 92; Zheng 2003). In Jenkins 1989, the
distal wires were orientated so that they transfixed comminuted
fractures (such as die punch fractures) of the distal fragment before
the external fixator was assembled.
A concise summary of the participants, fracture type, timing and
details of the interventions for the 15 trials is given in Table 4.
Table 4. Key characteristics of participants, fractures and interventions
11
Study ID
Participants
gender, age)
(Continued)
(N, Fracture Type/Clas- Timing of surgery/ Fixation
sification
Reduction
Conservative treatment
Abbaszadegan 1990 47; 77% female; Displaced (5+ mm After closed reducmean age 63 years. radial
short- tion and plaster cast
ening); extra-articu- for 1-3 days.
lar and intra-articular. Colles’. Older 3
& 4.
Skin incision for Closed reduction
pins. Trans-articu- and plaster cast for 4
lar fixation. External weeks
Hoffman fixator for
4 weeks.
Hegeman 2004
32; 91% female; Displaced (> 10 demean age 70 years. grees dorsal angulation and < 20 degrees radial inclination and > 3 mm
positive ulnar variance) unstable intraarticular. AO C2 or
C3.
No details of pin insertion. Trans-articular fixation. Hoffmann II compact
external fixator for 6
weeks
Horne 1990
37; % female un- Displaced extra-ar- Not stated but day
known; mean age 72 ticular and intra-ar- care surgery after
years.
ticular. (Colles’ im- presentation to fracplied) Frykman 1, 2, ture clinic. Closed
3, 4, 5 and 8.
reduction.
Stab
Closed reduction
incision for pins. and plaster cast for 5
Trans-articular fixa- weeks.
tion. Modified AO
tubular external fixator for 5 weeks.
Howard 1989
50; % female un- Severely
disknown; mean age 47 placed (30 degrees
years.
dorsal angulation / >
10 mm radial shortening) comminuted
Colles’ fracture. Intra-articular
fractures included.
“Careful” pin insertion. Trans-articular
fixation. MediumC-Hoffman external fixator for 5 to 6
weeks.
Jenkins 1989
153; % female un- Displaced. Extra-ar- Probably closed reknown; mean age 44 ticular and intra-ar- duction at fracture
years.
ticular.
Colles’. clinic. Operation on
Frykman.
day of injury or following day.
Timing of intervention: not stated, but
after X-ray examination. Reduction
(probably closed).
Not stated, usually
next
available
trauma list.
Reduction during
external fixation.
Closed
reduction and below elbow plaster cast for
6 weeks
Closed
reduction and below elbow plaster cast for
5 to 6 weeks.
Stab incision for Closed reduction
pins. Non-bridging and plaster cast for 4
fixation (not across weeks.
wrist joint). The distal wires transfixed
the comminuted (if
present) distal radial
fragment. AO/ASIF
external mini-fixator for 4 weeks.
12
(Continued)
Kapoor 2000
61 of 90 in comparison; 25% female;
mean age of whole
trial group was 39
years.
Displaced (dorsal or
volar). All intra-articular. Frykman (3,
4, 7 and 8) and AO.
Not
stated, but acute injury treatment. No
details of reduction
method.
No details of pin in- Closed reduction
sertion. Trans-artic- and plaster cast for 6
ular fixation. Roger to 7 weeks.
and Anderson external fixator, rigid
frame, for 6 to 7
weeks.
Kreder 2006
113; 65% female; Displaced (but < 10
mean age 53 years. degrees dorsal tilt/
angulation) with metaphyseal comminution
(< 1/3rd of radius
diameter). Extra-articular and intra-articular (stable congruous joint). AO A
and C.
Not stated but
within 1 week of injury. Closed reduction under regional
anaesthesia.
Skin incision for insertion of pins into
radial shaft. Transarticular fixation.
Small AO fixator for
6 to 8 weeks. Optional percutaneous
K-wire fixation: removed 4 to 6 weeks.
Lagerstrom 1999
35; 86% female; Displaced (10+ demean age 58 years. grees dorsal angulation / radial angulation; 3+ mm radial shortening) intra-articular Colles’
fracture. Frykman 5
to 8.
Not
stated, but probably
acute. No details of
reduction method.
No details of pin Below elbow plaster
insertion. Light (in cast for 6 weeks.
weight) non-cylindrical AO external
fixator for 6 weeks.
McQueen 1996
90 of 120 in comparison; 90% female; mean age 64
years.
Pring 1988
75; 81% female; Displaced
mean age 62 years. Colles’ fracture. Extra-articular and intra-articular.
Closed reduction
and long arm splint
for up to 2 weeks,
then long arm cast
which was reduced
to a short arm cast
at 3 to 4 weeks; removed 6 to 8 weeks.
Redisplaced (> 10 Within 2 weeks Open incisions for Closed reduction
degrees dorsal angu- from injury. Closed pin insertion. Trans- and plaster cast for 6
lation or > 3 mm reduction.
articular fixation. weeks.
radial shortening).
Pennig external fixaAO types A and C
tor for 6 weeks. Ball
(extra-articular and
joint released for
intra-articular).
limited wrist motion in 30 participants at 3 weeks.
After accident and
emergency attendance and closed reduction using Chinese finger traps.
PerClosed reduction
cutaneous pin inser- and forearm plaster
tion. Trans-articular cast for 5 weeks.
fixation. Pins incorporated into plaster
cast. Cast removed
after 5 weeks.
13
(Continued)
RodriguezMerchan 92
70; 17% female; Comminuted intra- Probably closed remean age 36 years. articular fractures. duction on first day
Frykman 3 to 8.
after injury and operation then or next
day.
Rouman 1991
43; % female un- Redisplaced Colles’ At 2 weeks. Closed No details of pin Plaster cast continknown; age over 55 fracture
reduction.
insertion. Trans-ar- ued for 5 weeks.
years.
(>10 degrees dorsal
ticular fixation. Ace
angulation or > 5
Colles external fixamm radial shortentor for 5 weeks.
ing). All intra-articular. Frykman (5 to
8) and Sarmiento.
Stein 1990
62; % female un- Comminuted disknown; mean age 50 placed intra-articuyears.
lar fractures. Older 3
and 4 (thus Colles’).
Not stated but after
presentation to fracture clinic. Admission to hospital for
24 hours or day care
facility for surgery.
Closed reduction.
No details of pin insertion. Trans-articular fixation likely.
“Small” AO external
tubular fixator for 6
weeks.
Young 2002
125; 78% female; Displaced (> 10 demean age 57 years. grees dorsal angulation or > 2 mm radial shortening) distal radial fractures.
Extra-articular and intra-articular. Colles’. Frykman: all grades (18).
Not stated. Closed
reduction. Hospital
admission for external fixation.
PercutaClosed reduction
neous pin insertion and forearm plaster
for 2nd metacarpal, cast for 6 weeks.
direct vision for insertion into radial
shaft. Trans-articular fixation. Pennig
external fixator for
6 weeks. Ball joint
released for limited
wrist motion at 3
weeks.
Zheng 2003
29; 48% female, Closed unstable disrange 18 - 52 years tal radial fracture.
Universal classification (Cooney) 2B,
2C (extra-articular),
4B, 4C (intra-artic-
Not stated. Closed
or open reduction.
Participants were either outpatients or
inpatients.
Pins
inserted Closed reduction
through skin inci- and forearm plaster
sions. Trans-articu- cast for 6 weeks.
lar fixation. Small
size Zhongjia SGDtype unilateral mul-
Pins
Closed reduction
driven into bone. and forearm plaster
Trans-articular fixa- cast for 7 weeks.
tion. Clyburn dynamic external fixator for 7 weeks. Posterior splint applied
for 3 weeks if joint
disrupted. Optional
K wire inserted for 3
weeks if joint unstable.
Closed
reduction and above-elbow plaster cast for
6 weeks.
14
(Continued)
ular).
tifunctional external
fixator.
Optional Kirschner
wire
for
unstable fractures. Fixator made dynamic
and K-wire removed
from week 4. Fixator removed after 6
weeks.
Excluded studies
Five studies were excluded for reasons stated in the ’Characteristics of excluded studies’ table. Four studies were found not to be
randomised trials and there was insufficient information on one
quasi-randomised trial (Sprenger 1988), published only as an abstract. (The latter trial appeared as an included trial in Handoll
2003a.)
Ongoing studies
No ongoing studies were identified.
Studies awaiting assessment
The possible inclusion of Moroni 2004 requires a response from
the lead author concerning the numbers allocated to each group.
Risk of bias in included studies
The quality of trial methodology, judged using the 11 quality criteria listed in Table 2, is disappointing. Associated with this is
a high potential for the key systematic biases (selection, performance, assessment and attrition) leading to questions about internal validity, and issues of clinical relevance and applicability or
external validity. These will be considered further in the ’Discussion’. The results, together with some notes on specific aspects, of
the quality assessment for the individual trials are shown in Table
5. Information specific to the first three items of the quality assessment is given in the methods sections of the ’Characteristics
of included studies’ table. A summary of the results for individual
items of quality assessment is given below.
Table 5. Quality assessment results for individual trials (see Table 03 for scheme)
Study ID
Items and grades
Items and grades
Items and grades
Study ID
Item 1: Allocation concealment
Item 2: Intention-totreat analysis
Item 3: Outcome asses-
Item 5: Participant
blinding
Item 6: Treatment
provider blinding
Item 9: Well defined out- Comments and explanacome measures
tions for specific items
Item 10: Optimal outcome assessment
Notes
15
(Continued)
sor blinding
Item 7: Identical care
Item 4: Comparable programmes
baseline characteristics
Item 8: Clearly defined
inclusion criteria
Item 11: Optimal timing
of follow up (> 1 year)
In brackets: date of last
follow up; % lost to last
follow up
Abbaszadegan 1990
?, Y, N, N
N, N, N, Y
Y, ?, ? (1 year; 2%)
Item 4: separate age, sex
and type of fracture data
not provided.
Hegeman 2004
?, Y, N, Y
N, N, ?, Y
Y, ?, ? (1 year; 0%?)
Item 7: method(s) of
anaesthesia not given.
Horne 1991
?, N, N, N
N, N, ?, ?
Y, N, N (4 - 15 months; Item 2: discrepancies in
22%)
numbers followed up in
the two groups.
Item 4: baseline data not
provided for all participants.
Howard 1989
?, Y, N, ?
N, N, Y, Y
Y, ?, Y (10 years; 20% or Item 2: although “Y”
22%)
there were some data discrepancies between the
two abstracts reporting
the long-term follow up.
Jenkins 1989
N, ?, N, N
N, N, N, ?
Y, ?, Y (13 months; 19%) Item 4: There was a
10 year difference in the
mean ages of the two
groups (38 versus 48).
Item 8: The maximum
age differed between 65
in the Masters thesis and
60 in the 2 journal publications.
Kapoor 2000
?, N, N, ?
N, N, N, ?
Y, ?, Y (mean 4 years; Item 2: no mention of
33%)
loss to follow up but
fewer participants in the
analyses at 4 years.
Kreder 2006
Y, Y, N, Y
N, N, ?, Y
Y, Y, Y (2 years; 25%)
Item 7: regional aneasthesia was used in the external fixation group and
haematoma block in the
plaster group.
16
(Continued)
Lagerstrom 1999
?, ?, N, N
N, N, Y, Y
Y, ?, Y (2 years; 6%)
McQueen 1996
?, Y, N, ?
N, N, ?, Y
Y, ?, ? (1 year; 9%)
Pring 1988
?, N, N, ?
N, N, ?, N
Y, ?, ? (6 months; 12%)
Item 2: 9 people from the
plaster group were given
external fixation and reportedly analysed separately but no data were
given.
Rodriguez-Merchan 92
?, ?, N, ?
N, N, ?, Y
Y, ?, ? (1 year; 0%?)
Item 1: though described
as “double-blind”, no details were given of the
method of randomisation.
Roumen 1991
?, N, N, N
N, N, N, Y
Y, ?, ? (6 months; 0%?)
Item 2: It is possible that
some patients who were
lost to follow up (17) or
had died (2) from the initial group of 126 people with displaced fractures would have be included in the trial should
their fractures have redisplaced.
Stein 1990
N, ?, N, N
N, N, N, Y
?, N, ? (6 months to 4 Item 10: The final folyears; 0%?)
low up of participants,
recruited over a 4 year
period, ranged from 6
months to 4 years.
Young 2003
?, Y, N, ?
N, N, ?, Y
Y, ?, Y (7 years; 31%)
Zheng 2003
N, ?, N, N
N, N, ?, ?
Y, ?, ? (1 year; 0%?)
Item 4: key patient characteristics were not split
by group except for gender. There were males
(5/18) in the external fixation group but none
(0/17) in the plaster
group.
Item 4: Insufficient information but also imbalance in number of
males (5 versus 10).
17
Allocation concealment (item 1)
Only one trial (Kreder 2006), which used sealed opaque sequentially marked envelopes, was considered to have satisfied the criteria for secure allocation concealment. It was unclear whether allocation was concealed prior to randomisation in 11 trials. Three
of these used envelopes (Hegeman 2004; McQueen 1996; Young
2003), one used a computer (Lagerstrom 1999) and seven trials provided no information (Abbaszadegan 1990; Horne 1990;
Howard 1989; Kapoor 2000; Pring 1988; Rodriguez-Merchan 92;
Roumen 1991). The three remaining trials used quasi-randomised
methods based on dates of birth (Jenkins 1989), day of hospital
admission (Stein 1990) and admission number (Zheng 2003).
Intention-to-treat analysis (item 2)
Clear statements of participant flow with evidence of intentionto-treat analysis were available for six trials (Abbaszadegan 1990;
Hegeman 2004; Howard 1989; Kreder 2006; McQueen 1996;
Young 2003). Failure to provide the numbers assigned to each
group at randomisation, post-randomisation exclusions, inappropriate analyses and lack of accountability of losses were reasons
for a ’N’ rating for four trials (Horne 1990; Kapoor 2000; Pring
1988; Roumen 1991).
Blinding of outcome assessors (item 3)
No trial reported blind outcome assessment although four trials (
Howard 1989; Kreder 2006; Pring 1988; Young 2003) referred to
independent assessors for some outcomes. Total blinding of outcome assessment is impractical for trials testing surgical interventions but it is possible for some outcomes and more so at longerterm follow up.
Comparability of baseline characteristics (item 4)
Two trials (Hegeman 2004; Kreder 2006) provided sufficient information indicating the similarity in the baseline characteristics
of gender, age and type of fracture. Potentially important imbalances between treatment groups in participant characteristics,
where information was provided, were found in Jenkins 1989
(age), Lagerstrom 1999 (gender) and Zheng 2003 (gender).
Blinding of patients and treatment providers (items 5 and 6)
These are unlikely in these studies and none was claimed.
Care programme comparability (item 7)
We found it difficult to confirm comparability of care programmes
other than the trial interventions, although we judged it highly
likely in two trials (Howard 1989; Lagerstrom 1999). Systematic
differences between the arms of a trial, such as the different methods of anaesthesia for closed reduction in Kreder 2006, can change
the actual comparison under test.
Description of inclusion criteria (item 8)
Ten trials provided sufficient trial inclusion and exclusion criteria
to define their study populations. This item was rated ’N’ (“not
met”) in Pring 1988 where no details of the type of fractures
included were available aside from “Colles”’.
Definition of outcome measures and quality of outcome measurement (items 9 and 10)
The definition of outcome measurement was clear enough to give
a good idea of what was recorded in all of the included trials except
Stein 1990. Two trials (Horne 1990; Stein 1990) were considered
to have inadequate outcome measurement, which included follow
up of variable duration. Only Kreder 2006 was rated as having
’optimal’ quality outcome measurement, which included use of
validated patient assessed quality of life instruments and active
follow up. Nonetheless, several other trials (including Hegeman
2004; McQueen 1996; Young 2003) had active follow up and
applied clearly relevant measures of function. Of note is the grading or scoring of overall functional outcome according to nonvalidated scoring systems in several trials. These systems, which
often included anatomical and clinical outcomes, included modifications of other scoring systems such as that of Gartland and
Werley (Gartland 1951). Also, noted but not rated, were instances
where adjustments were made for hand dominance. The variety of
schemes used and other outcome measures reported by the trials is
evident from inspection of the ’Characteristics of included studies’
table.
Length of follow up (item 11)
Follow up ranged from a minimum of four months (Horne 1990)
to 10 years (Howard 1989). Follow up of variable duration at
times where participants are at different stages of recovery, may
be a potential cause of bias in Horne 1990 (4 to 15 months) and
Stein 1990 (6 months to 4 years).
Loss to follow up (not rated)
Loss to follow up was substantial in several trials (see ’Characteristics of included studies’ table and Table 5). Nearly a third of participants were missing from the final analyses of Kapoor 2000 and
Young 2003. The latter trial, however, gave a full account of the
losses at seven years whereas losses were not explained in Kapoor
2000. For some of the trials appearing to have no losses, it may be
the case that these were not reported.
Effects of interventions
In the following, the results are presented for the basic comparison, namely external fixation versus plaster cast immobilisation,
despite the evident variation among the trials in patient characteristics and interventions (see Table 4), and in the methods and
timing of outcome assessment and selection of reported outcomes
(see below and ’Characteristics of included studies’ table). Furthermore, few of the trials are sufficiently similar to fall neatly
into specific sub-categories. For instance, the pooling of data from
the two trials studying treatment of redisplaced fractures in older
18
people (McQueen 1996; Roumen 1991) would appear valid but
there remains clear dissimilarity in the known characteristics of
the trials (e.g. different types of external fixator; the re-reduction
of fractures in the conservative treatment group and the inclusion
of extra-articular fractures in McQueen 1996 but not in Roumen
1991). Hence, whilst some exploratory analysis has taken place,
we considered that, on the whole, subgroup analysis was not appropriate. Separate data for participants in the three trials with
optional supplementary pinning were not available.
Functional outcome and impairment
Final overall functional outcome, or some aspect of function, was
considered better in the external fixation group in eight studies (
Abbaszadegan 1990; Howard 1989; Jenkins 1989; Kapoor 2000;
Pring 1988; Rodriguez-Merchan 92; Stein 1990; Zheng 2003). No
statistically significant differences in final functional outcome were
reported by seven studies (Horne 1990; Kreder 2006; Lagerstrom
1999; McQueen 1996; Pring 1988; Roumen 1991; Young 2003).
Though some statistically significant differences in some aspects
of function were apparent at one year follow up in Young 2003,
the trialists considered that the differences were not clinically significant; nonetheless we have presented these as well as the seven
year results in the analyses.
’Functional’ scores
’Functional’ scoring systems were used in 13 of the trials (
Abbaszadegan 1990; Hegeman 2004; Horne 1990; Howard 1989;
Jenkins 1989; Kapoor 2000; Kreder 2006; Pring 1988; RodriguezMerchan 92; Roumen 1991; Stein 1990; Young 2003; Zheng
2003); most were modifications of Gartland and Werley’s scheme
(Gartland 1951). Some consideration of deformity was present in
the schemes used by Abbaszadegan 1990, Hegeman 2004, Kapoor
2000, Pring 1988 and Roumen 1991; whilst various complications
were included in that used by six trials (Hegeman 2004; Horne
1990; Howard 1989; Kapoor 2000; Young 2003; RodriguezMerchan 92). The functional scores were usually graded into four
categories (’excellent’, ’good’, ’fair’ and ’poor’). However, some trials reported results for combined categories (such as fair or poor)
only. Jenkins 1989 and Stein 1990 presented results split by subjective and objective gradings. The subjective end gradings from
Jenkins 1989 and Stein 1990 were pooled with the overall functional gradings from the other studies in Analyses 01.01, 01.02 and
0.03. A higher proportion of people treated with external fixation
achieved an excellent functional grading; in other words, a lower
proportion of people treated with external fixation had a “not excellent” grading (see Analysis 01.01: 134/256 versus 166/265; RR
0.82, 95% CI 0.71 to 0.95). Analysis 01.02 shows a worst-case
(for conservative treatment) and then a best-case analysis for this
outcome. The result strongly favours external fixation when it is
assumed that all participants lost to follow up or excluded (not
possible for Horne 1990) in the external fixation group had an
excellent result compared with none of those lost or excluded from
the conservative treatment group. In the converse case, a neutral
result is obtained (RR 1.09, 95% CI 0.95 to 1.25). More people
in the external fixator group achieved excellent grades at 10 years
in Howard 1989 but the data presented in the two abstract reports
for long-term follow up were inconsistent. As shown in Analysis
01.03, the numbers with an unsatisfactory outcome (either fair or
poor gradings) were statistically significantly fewer in the external
fixation group (62/308 versus 83/304; RR 0.73; 95% CI 0.55
to 0.98; fixed-effect model). This was not statistically significant
when using the random-effects model (RR 0.72; 95% CI 0.47
to 1.09: analysis not shown). The significant heterogeneity (P =
0.07; I² = 41.4%) is lost on the removal of the results of Roumen
1991 and the result is again statistically significant (RR 0.65, 95%
CI 0.47 to 0.88; analysis not shown). In summary, these pooled
results from non-validated ’functional’ scoring schemes favour external fixation in terms of more people with excellent results (depicting a good recovery) and fewer people with an unsatisfactory
outcome (either ’fair’ or ’poor’ result). However, as shown by the
results of sensitivity analyses (e.g. Analysis 01.02) such findings
are not robust.
Analysis 01.04 presents the separate subjective and objective results
reported in Jenkins 1989 and Stein 1990: here it is notable that the
trial participants of Jenkins 1989 rated the end functional result
less favourably than the result using objective measures. Kreder
2006 found non-significant trends to better functional results for
the surgical group in the upper extremity function part of the Musculoskeletal Function Assessment tool (see Analysis 01.05), and in
the results for the bodily pain domain of the SF-36 and JebsenTaylor (Jebsen 1969) hand function scores (data reported as standard deviations from the norm for these outcomes are not presented in the Analyses). The mean ’demerit’ Scheck score (Scheck
1962) for function was better, but not statistically significantly so,
in the external fixation group of Pring 1988 at six months (3.30
versus 4.19).
Activities of daily living
At three months, more people in the external fixation group of
Hegeman 2004 had problems with some activities of daily living; this was significant for fine hand co-ordination (see Analysis
01.06). None of the differences were significant at one year for
Hegeman 2004. Young 2003 found similar numbers of people in
the two groups experiencing difficulties with specific functional
tasks at seven years (see Analysis 01.06).
Occupation
There was no significant differences between the two groups of
Kreder 2006 in the numbers of people who changed their job
because of their injury at six months, one year or two years (see
Analysis 01.07). The time to return to work or normal activities
averaged 70 versus 75 days in Young 2003 (statistical significance
not reported).
Grip strength
The greater grip strength in the external fixation groups of Jenkins
1989 and Young 2003 (1 year data) was statistically significant (see
Analysis 01.08). Kapoor 2000 found a marginally statistically significantly better restoration of grip strength in the external fixation
19
group (70% versus 63% of unaffected arm; reported P = 0.05).
The differences between the two groups in mass grip strength were
found not to be statistically significant at final follow up in seven
trials: Abbaszadegan 1990, Hegeman 2004 (see Analysis 01.08),
Kreder 2006 (see Analysis 01.09); Lagerstrom 1999 (see Analysis
01.10), McQueen 1996 (see Analysis 01.08), Pring 1988 (mass
grip strength as % of normal side: 67.6% versus 63.8%) and Young
2003 (7 year results: see Analysis 01.08). Due to the statistically significant heterogeneity (P = 0.004; I² = 77.6%) in the results of the
four trials (Hegeman 2004; Jenkins 1989; McQueen 1996; Young
2003) providing data for grip strength, these were not pooled.
Lagerstrom 1999, who measured isometric grip strength, found
that the recovery in grip strength was slower in the external fixator group and considered there was some indication for specific
physiotherapy for patients treated by external fixation. One person in the external fixator group in Young 2003 at seven years had
persistent wrist weakness necessitating a wrist splint.
Pain
Pain was reported as being significantly less in the external fixator
group in Abbaszadegan 1990 (final mean visual analogue score
(0 to 10 severe): 0 versus 1; reported P < 0.002) but numbers
with persistent pain were reported to be similar in Hegeman 2004,
Lagerstrom 1999 (19% overall had persistent pain after two years;
separate data by intervention group were not available) and Young
2003 (see Analysis 01.11). Roumen 1991 reported the numbers
of patients experiencing pain: at rest, during movement and ulnar
compression pain. There were no statistically significant differences for any of these three measures (see Analysis 01.12). Young
2003 also gave details of the circumstances for persistent pain at
seven years; notably the constant pain on movement of the wrist
in two people in the external fixation group was sufficient for them
to adapt their activities to avoid using the wrist.
Range of movement
The available data for range of movement are presented in Analyses 01.13 to 01.16. The difference in the flexion/extension arc values were reported as being statistically significant, in favour of the
external fixator group, in Abbaszadegan 1990 (% of normal wrist:
95% versus 83%; reported P = 0.0002), but not in McQueen 1996
(see Analysis 01.13). McQueen 1996 also found no difference in
the overall range of motion. Only wrist extension was better in the
external fixation group at one year in Hegeman 2004. There were
no statistically significant differences in range of motion outcomes
at one year for Jenkins 1989 (see Analysis 01.13). There was no
indication in Kapoor 2000 as to whether the superior range of
motion in the external fixator group was reflected in statistically
significant differences in the losses in the following three parameters: dorsi-palmar flexion (19 versus 37 degrees); radial-ulnar deviation (13 versus 16 degrees); pronation-supination (23 versus
40 degrees). Kreder 2006 reported there was no statistically significant differences in wrist and forearm range of motion at any
of the follow ups, on the application of the Bonferroni correction
for multiple comparison testing. The clinical implications of the
significant findings, when not using the Bonferroni correction, for
Kreder 2006 at two years in favour of external fixation in flexion
and radial deviation, and in favour of plaster cast for supination,
are not known but are likely to be minor (see Analysis 01.14).
Though statistically significant, the differences between the two
groups in ulnar deviation and pronation at one year follow up in
Young 2003 are not clinically important (see Analysis 01.15); there
were no statistically significant differences in range of motion outcomes at seven year follow up of this trial (see Analysis 01.16).
Clinical outcome and complications
Complications
The various complications suffered by the participants of these trials are presented in Analysis 01.17. Null events have also been entered when reported. Redisplacement resulting in secondary treatment mainly occurred in the conservative treatment groups, the
exceptions being three participants whose external fixator was distracted to combat radial shortening in Howard 1989, one participant given open reduction and internal fixation in Kreder 2006
and three participants who underwent remanipulation in Young
2003. Similarly, redisplacement or, as in McQueen 1996, recurrent instability of already redisplaced fractures were significantly
more common in conservatively treated participants.
Pin-site infections in 10 of the 69 people with pin-track infections
(61/444 versus 1/402; RR 12.02, 95% CI 5.07 to 28.49) did not
resolve with cleansing and antibiotics or, in Kreder 2006, with the
early removal of supplementary percutaneous pins. Of the three
serious infections in Jenkins 1989, two infections were recurrent
and resulted in fixator removal and one developed into the only
reported case of osteomyelitis. Surgical curettage of the pin tracks
was required for two people in Kreder 2006. Two infections resulted in fixator removal in McQueen 1996, and the third required
curettage. The two infections in Stein 1990 resolved on fixator removal; it is not clear whether this was premature. Some reference
to care of pin sites was made in six trials (Howard 1989; Jenkins
1989; Kapoor 2000; Kreder 2006; McQueen 1996; RodriguezMerchan 92). There are 10 other cases of pin loosening or other
pin site problems (see Analysis 01.17). In addition, Pring 1988 reported several complications for external fixation including thumb
pain and various pin-related problems (see ’Characteristics of included studies’ table) but failed to distinguish between primary
and secondary external fixation.
Radial nerve neuropathy, often a short term sensory disturbance
of the superficial radial nerve, was more common in the external
fixator group; radial nerve symptoms in the plaster cast group
were reported in a few cases of Howard 1989 and Young 2003.
There was a marked excess of nerve related complications in the
conservative treatment group in Howard 1989 that was not so
apparent in the other trials.
The majority of cases of reflex sympathetic dystrophy (RSD) were
reported as serious, requiring many months of intensive physiotherapy to resolve. There is no statistically significant difference
20
between the two groups (25/384 versus 17/347; RR 1.31, 95%
CI 0.74 to 2.32) in RSD. Previously, in Handoll 2003a, it was
noticed that the two trials (McQueen 1996; Roumen 1991) including redisplaced, and hence unstable, fractures as well as older
participants had more cases of RSD in the external fixator group,
in contrast to most of the other included trials. As before, an exploratory analysis (see Analysis 01.18) was set to examine the difference in the direction of effect of the two subgroups (primary
displaced fractures versus redisplaced fractures). As the difference
between the two results is not statistically significant (P = 0.191)
more evidence is required to establish if external fixation has a
greater risk of RSD in older people with proven unstable fractures.
It should also be noted that the differences between the two treatment groups in either subgroup of trials did not reach statistical
significance.
Most cases with arthritis at seven years had mild cases of joint
space narrowing in Young 2003 (11 versus 12); only one was
symptomatic. The severity of the arthritic changes at 10 years in
Howard 1989 was not reported (see Analysis 01.17).
Cosmetic outcomes
There were no significant differences between the two groups
in overall cosmetic deformity (Kapoor 2000) or various features
of cosmetic deformity described in Hegeman 2004 (see Analysis
01.19). Howard 1989 reported that the pin-track scars were accepted by the patients; the only complaint being that the fixator
made it difficult to use the hand. In Young 2003, 13 of the 36
people available at seven year follow up had “unsightly” forearm
scars at the proximal pin insertion sites. Young 2003 found there
was no difference between the two groups in the few people who
were dissatisfied with their wrist at seven years (see Analysis 01.20).
Anatomical outcome (anatomical restoration and residual deformity)
Overall anatomical results at final radiological follow up were better, often significantly so, in the external fixation group in all trials
except Horne 1990. The results of Horne 1990 may in part reflect the choice of radiological parameters (Van der Linden 1981)
reported in Horne 1990 and the small numbers of participants (
Axelrod 1991). Differences between the one year and seven year
results for radial shortening (see Analysis 01.23) and dorsal angulation (see Analysis 01.24) in Young 2003 probably reveal a trend
for deterioration over time but other factors, including the reduction in the sample size at seven years, may also influence these
results. All the other trials indicated that external fixation held
the reduced position better than plaster cast immobilisation. Redisplacement requiring secondary treatment occurred in 15% of
conservatively treated fractures over nine trials (see Analysis 01.17:
7/356 versus 51/338; RR 0.17, 95% CI 0.09 to 0.32). Exceptionally, there were similar numbers of people in the two groups with
redisplacement and treated redisplacement in Young 2003. Secondary treatment for redisplaced conservatively treated fractures
consisted of remanipulation and external fixation in Abbaszadegan
1990, Lagerstrom 1999 and Pring 1988; these participants were
then analysed as a separate group in these three trials. External
fixation group participants with serious infection and plaster cast
group participants requiring remanipulation were excluded from
the rest of the analyses in Jenkins 1989. It is of concern to note
that four people were recorded as requiring remanipulation in the
full report of this trial, but six in another report (Jenkins 1988).
Howard 1989 (external fixator group: distraction of the fixator
increased for loss in radial length; plaster cast group: remanipulation), Kreder 2006 (external fixator group: open reduction and
internal fixation; plaster cast group: external fixation if remanipulation was unsuccessful), Stein 1990 (plaster cast group: remanipulation) and Young 2003 (both groups: remanipulation) all retained those participants confirmed as having secondary treatment
for redisplacement. Most of the 27 redisplacements occurring in
the conservative treatment group in Rodriguez-Merchan 92 were
probably remanipulated, but this was not stated explicitly in the
trial report. Kreder 2006 reported that similar numbers had distal
radius ulnar joint instability at six weeks (3/54 versus 2/59; RR
1.64, 95% CI 0.28 to 9.44); one person in the external fixation
group had stabilisation of this joint by ulnar styloid repair. Statistically significantly fewer people in the external fixator group had
recurrent instability in McQueen 1996 (14/60 versus 16/30; RR
0.44, 95% CI 0.25 to 0.77).
Anatomical scores
Four of the six trials rating overall anatomical results used the same
rating scheme (Stewart 1984; Stewart 1985) which was derived
from the scheme used by the two other trials (Roumen 1991;
Stein 1990). The pooled results from these six trials give a consistent picture of the significantly superior anatomical results for
external fixation (see Analysis 01.21 Anatomical grading: not excellent. 90/202 versus 148/169; RR 0.53, 95% CI 0.45 to 0.61;
and Analysis 01.22 Anatomical grading: fair or poor. 17/214 versus 96/186; RR 0.17, 95% CI 0.11 to 0.27). It should be noted
that the removal of the highly favourable results for the external
fixation group of Stein 1990 shows these to be the basis of the statistically significant heterogeneity (P = 0.02; I² = 67%) in Analysis
01.21. This may be associated with the significantly better postreduction results in the external fixation group of this trial, despite
closed reduction being used in both groups.
Radiological parameters
The differences, in favour of the external fixation group, between
the two treatment groups in the mean values of individual radiological parameters were reported to be statistically significant, often without confirmatory data, in eight trials: Abbaszadegan 1990
(dorsal angulation; radial shortening); Hegeman 2004 (dorsal angulation, radial angulation); Howard 1989 (dorsal angulation; radial shortening); Jenkins 1989 (dorsal angulation; loss in radial angulation; radial shortening), McQueen 1996 (dorsal angulation),
Pring 1988 (radial angulation; from graph), Young 2003 (dorsal
angulation (at one year); radial shortening); Zheng 2003 (dorsal angulation; ulnar angulation; radial shortening. Rodriguez-
21
Merchan 92 also reported superior results in the external fixator
group; for example, dorsal angulation (mean: 0.2 versus 9.5 degrees) and loss of radial length (mean: 0.5 mm versus 4.1 mm).
Losses in various radiological parameters in those trials providing
sufficient data are presented in Analysis 01.23. This shows that all
losses in these parameters were less in the external fixation group,
with two exceptions (Horne 1990: dorsal displacement; McQueen
1996: radial shortening). Since statistically significant heterogeneity (I² = 94.9%) was evident for radial shortening, pooling was
not performed. The data presented in the analyses for Jenkins
1989 pertain to the time of fracture union and removal of cast
and fixator at around four weeks. Later data at one year for this
trial showed a further loss in mean radial length in the external
fixator group compared with a slight gain in the cast group (mean
loss: 1.24 mm versus -0.70 mm). Radial length shortening had
worsened in both groups of Young 2003 at seven year follow up
and the difference between the two groups was no longer statistically significant (see Analysis 01.23); however, the difference was
reported to be statistically significant in both the draft and published reports (P < 0.05). Kreder 2006 reported the trend for better
restoration in radial length and palmar tilt (volar angulation) in
the external fixation group was not statistically significant. Superior anatomical values for dorsal and radial angulation and radial
length were usually evident and claimed for the external fixation
group (see Analysis 01.24) but the variation in the definitions of
dorsal angulation and “normal” values makes the results hard to
interpret.
Residual deformity
Several other measures of structural deformity are presented in
Analysis 01.25. Trialist-defined ’malunion’ (based on dorsal angulation and radial shortening) reported by McQueen 1996 and
Young 2003 was significantly less in the external fixation group at
one year (36/108 versus 47/90; RR 0.58, 95% CI 0.41 to 0.81).
In contrast, the incidence of malunion in those patients available
at seven years follow up in Young 2003 was similar in the two
groups (RR 0.96; 95% CI 0.63 to 1.47). Jenkins 1989 found a
better reduction and fixation of die-punch fractures in the external
fixation group; this may reflect the particular design of non-bridging fixator used in this trial where the distal pins also transfixed
the fracture fragments.
Resource use
No trial provided quantitative data on resource use and costs. It is
not known how many people receiving surgery were day cases, thus
avoiding the costs of a hospital bed. Overnight hospital admission
was routine for surgical patients in Rodriguez-Merchan 92 whereas
Horne 1990 referred to a day-care facility. Stein 1990 referred
to admission to hospital for 24 hours or to a day-care facility.
There was no report of the cost implications of remanipulation of
redisplaced fractures or of the routine care of pin sites or additional
care resulting from pin site infection.
DISCUSSION
This review of a common surgical intervention for one of the
most common fractures has 15 included trials involving a total of
only 1022 participants. Though essentially these trials evaluated
one basic comparison, namely external fixation versus plaster cast
immobilisation, there was considerable variation in the trials especially in terms of patient characteristics and interventions (see
Table 4); and in their methods, including outcome assessment.
Limitations of the review methods
As this review abided by the criteria and methods set out in a
published protocol, we have restricted our comments to two issues.
The first is the question of whether trials have been missed or
inappropriately excluded in our search and selection processes.
The second issue concerns decisions made regarding pooling and
subgroup analysis.
Our search was comprehensive and built on searches carried out
over many years prior to the separate development of this review
(Handoll 2003a). It has included the handsearch of conference
proceedings and checks for ongoing trials. An inclusive and benefit-of-doubt approach during trial searches has been maintained
throughout by the lead author (HH). Additionally, trial authors
of unpublished trials have been sent requests for information and
trial reports. It is possible that we have missed some potentially
eligible trials but, if so, these may still not be suitable for inclusion, particularly if unpublished and inadequately reported. We
guarded against study selection bias by the independent selection
of eligible trials by all three review authors.
We decided to pool the results of evidently heterogeneous trials
in an attempt to address the basic question of whether external
fixation of any kind produces significantly different results compared with conservative treatment (plaster cast) in adults with distal radial fractures. We considered grouping trials by participant
age and gender according to the three categories described in ’Description of studies’; in particular to examine the results in good
quality bone in the younger age group compared with osteoporotic
bone in the older age group. However, we decided that any findings would be impossible to interpret given the other differences
in characteristics (types of fracture and interventions, assessment
of outcome, methodology) and quality of the studies in the different age groups. Thus we concluded that the subgrouping the
15 trials into smaller separate categories was not viable. We, however, made one exception by subgrouping according to primary
and secondary displaced fractures for RSD (see Analysis 01.18).
This reflected a previously set up hypothesis in Handoll 2003a. As
discussed below, our overall approach has important implications
in terms of the interpretation of review findings.
Limitations of the review evidence
Overall, the available evidence is limited in scope and quantity,
and is of uncertain validity. The usual reservations of the reliability
22
of evidence from small and underpowered trials apply. Especially,
we were careful to avoid mis-interpreting inconclusive evidence as
’evidence of no effect’. Systematic bias, in the form of selection,
performance, exclusion or assessment bias, or a combination of
these could not be ruled out for any trial. However, this was much
less a concern with Kreder 2006, which was the only trial with
clearly concealed treatment allocation. Another limitation was the
inadequate assessment of outcome, particularly of function and
in the long term. Non-validated outcome measures, such as those
based on the Gartland and Werley scoring system (Gartland 1951),
that combine aspects of function, pain, deformity and complications are particularly crude indicators of outcome.
Considerable caution is needed when interpreting these, especially
when the scores have been reduced into categories such as excellent, good, fair or poor. Many trials predated the development of
validated patient functional assessment instruments such as Short
Form-36 (SF-36), the Disability of the Arm, Shoulder, and Hand
questionnaire (DASH) and the Patient-Rated Wrist Evaluation
(PRWE) (MacDermid 2000). These help to standardise functional
assessment in a meaningful way and assist interpretation (Amadio
2001). Again, Kreder 2006 proved an exception.
Applicability of the review evidence
Generalising the findings of the included trials, should these be
valid, is hampered by inadequate reporting of study details: in particular, the type and severity of the fracture, and quality of bone,
all of which are key determinants of treatment and prognosis. The
variety of fracture classification systems, with associated issues of
reliability and validity further complicates this area (Jupiter 1997)
and hinders direct comparisons between trials. For example, the
two fracture classifications used by trials in this review (the AO and
Frykman) place different emphases on various fracture patterns
and anatomical components. Studies have revealed unsatisfactory
interobserver reliability and intraobserver reproducibility for both
classification systems (Andersen 1996; Kreder 1996b). Moreover,
a large retrospective study found that neither classification system
was useful for predicting clinical outcome (Flinkkila 1998). Thus,
both fracture classification systems have been shown to have serious limitations. Nine trials in this review stipulated criteria for
anatomical displacement of the fracture for trial entry. However,
Kreder 1996a found quite broad margins of error (“tolerance limits”) for anatomical measurements in general. This with other factors, such as variations in anatomical reference points, again hinders treatment comparison.
Fracture instability was the inherent or explicit criterion for many
of the included trials, and proven for the two trials of redisplaced
fractures (McQueen 1996; Roumen 1991). Generally though it is
not established how best to predict fracture instability. A study of
4024 patients concluded that the patient age, metaphyseal comminution of the fracture and ulnar variance were the most important factors in predicting instability of distal radial fractures (
MacKenney 2006).
Summary of the evidence
We have summarized the evidence using the categories described
in BMJ 2006 (see Table 3). The effectiveness of external fixation
compared with conservative treatment is graded as 3 (’Trade off
between benefits and harms’) as defined in Table 3. Some supporting information is provided in Table 6 and below.
Table 6. Category of effectiveness for external fixation versus conservative treatment
Comparison
Category
Justification
External fixation (EF) 3: Trade off between EF
reduces
redisversus conservative treat- benefits and harms
placement requiring secment
ondary treatment (usually remanipulation under anaesthesia in the
plaster cast group) and
yields better anatomical
results. However, the evidence of a better functional outcome from EF
is weak. Moreover, EF
is associated with a high
risk of complications.
Pin site infection, while
common, is generally re-
Qualifiers
Comments
(1)
Indications
(
especially fracture types)
for treatment; and type,
technique and timing of
EF not resolved.
(2) Incomplete functional and long term outcome.
(3) Heterogeneous interventions, patient characteristics.
(4) Compromised methods
of
several
trials means that serious
bias cannot be ruled out.
Minimal
details were usually provided for the conservative treatment intervention which always involved plaster cast immobilisation. There remains a possibility of
suboptimal application
of plaster casts in some
trials.
Some
EF
techniques were not optimal
- increased risk of iatro-
23
Table 6. Category of effectiveness for external fixation versus conservative treatment
(Continued)
solvable with local treatment. Other complications, such as superficial
radial nerve paraesthesia,
are less common but often more serious.
Superior anatomical results, both in maintaining the reduced
fracture position and in final anatomy, in the external fixation
group were evident in all trials except Horne 1990 and Young
2003. Putative reasons for these two exceptions are given in the
Results. The functional results of the included trials presented a
mixed and incomplete picture, albeit potentially favouring external fixation, that is to a great extent based on functional grades
from non validated scoring systems that also rate radiological deformity. As explained above, there are insufficient data to explore
the effects of different trial characteristics, including age, on functional results.
Secondary displacement, here often termed redisplacement, after
primary reduction and recurrent instability after re-reduction in
redisplaced fractures was a frequent complication of conservatively
treated patients. Most of the redisplacements resulted in a second
reduction and application of a second plaster cast. Although some
redisplacements might be explained by operator error, this finding
is a reasonable indication of the instability of fractures in the trial
populations. However, though external fixation was more effective
in holding a reduced fracture position it comes at a price of a high
number of associated complications. Most of the complications
related to external fixator pins were pin-track infections that resolved with cleansing and antibiotics and there was a low incidence
of pin loosening and premature removal of the external fixator.
Radial nerve injury was more common in the external fixation
group and can be a consequence of poor pin placement resulting
from suboptimal surgical technique (Ahlborg 1999; Seitz 1993);
the use of stab incisions in Horne 1990 rather than small incisions to visualise and retract soft-tissue during pin insertion was
criticised (Axelrod 1991). RSD occurred in nearly six per cent of
patients (42/731); we could not confirm that RSD was more common in patients with redisplaced fractures that had been treated
by external fixation. Data for long-term complications and overall
outcome were too limited for comments, aside from their general
absence.
Sufficient data were not available to undertake meaningful subgroup analysis; e.g. fracture pattern, patient characteristics, variations in the interventions. The considerable variation in the trials
genic complications.
means that only the basic question of whether external fixation
confers some benefit is addressed here. Some clues as to the best
methods of external fixation may arise from the pending systematic review of the evidence from direct comparisons of different
methods of external fixation (Handoll 2007).
AUTHORS’ CONCLUSIONS
Implications for practice
There is some evidence from a set of 15 heterogeneous and generally methodologically weak trials to support the use of external fixation for dorsally displaced fractures of the distal radius in
adults. While the evidence shows that external fixation maintains
reduced fracture positions and prevents late collapse and malunion
compared with plaster cast immobilisation, there was insufficient
evidence to confirm a superior overall functional or clinical result.
External fixation was associated with a high number of complications but many of these were minor and some would probably
have been avoided using a different surgical technique for pin insertion. There was not enough evidence to prove or disprove a
difference in more serious complications between the two groups.
Implications for research
Given that a distal radius fracture in adults is a common injury
and given that there is limited knowledge about the best method
of treatment, either conservative or surgical, further research is
called for (Handoll 2003a). However, rather than embark on yet
more small single-centre trials, particularly those with inadequate
methodology that are unlikely to provide the good quality generalisable evidence required, the identification of the priority questions for the management of these fractures is required (Handoll
2003c). The updating of the evidence summaries of other surgical
interventions for these fractures is likely to inform this process.
ACKNOWLEDGEMENTS
24
We thank Lesley Gillespie for her help with the search strategy.
We thank the following for helpful comments and input at the
editorial and external review of the protocol: Joanne Elliott, Bill
Gillespie, Jesse Jupiter, Lindsey Shaw and Janet Wale. We thank the
following for helpful comments at the editorial and external review
of the review: Lesley Gillespie, Jesse Jupiter, Vicki Livingstone and
Janet Wale. We thank Joanne Elliott and Lindsey Shaw for their
help during editorial processing of the review.
We thank Xiaoyan Chen for a translation from Chinese. We thank
Jean Goodman, at the British Orthopaedic Association, for facilitating the perusal of the Jenkins’ trial thesis. We are also very
grateful to those trialists, in particular Claire Young for extensive
feedback, who provided clarification and further information on
their trials.
REFERENCES
References to studies included in this review
Abbaszadegan 1990 {published data only}
Abbaszadegan H, Jonsson U. External fixation or plaster cast for
severely displaced Colles’ fractures? Prospective 1-year study of 46
patients. Acta Orthopaedica Scandinavica 1990;61(6):528–30.
Hegeman 2004 {published data only}
Hegeman JH. personal communication October 10 2006.
∗
Hegeman JH, Oskam J, Van der Palen J, ten Dius HJ, Vierhout
PAM. Primary external fixation versus plaster immobilization of the
intra-articular unstable distal radial fracture in the elderly. Aktuelle
Traumatologie 2004;34(2):64–70.
Horne 1990 {published data only}
Axelrod TS. A prospective randomized trial of external fixation and
plaster cast immobilization in the treatment of distal radius
fractures. Journal of Orthopaedic Trauma 1991;5:114–5.
Devane P, Horne JG. A prospective trial comparing external
fixation with closed reduction and cast immobilisation in the
treatment of distal radial fractures [Abstract]. Journal of Bone and
Joint Surgery - British Volume 1988;70(3):507.
Horne G. A prospective randomized trial of external fixation and
plaster cast immobilization in the treatment of distal radius fractures
[letter; comment]. Journal of Orthopaedic Trauma 1991;5(2):246.
Horne G, Devane P. A prospective randomised trial of external
fixation and plaster cast immobilisation in the treatment of distal
radial fractures [Abstract]. Orthopaedic Transactions 1989;13(3):
531.
∗
Horne JG, Devane P, Purdie G. A prospective randomized trial of
external fixation and plaster cast immobilization in the treatment of
distal radial fractures [see comments]. Journal of Orthopaedic
Trauma 1990;4(1):30–4.
Howard 1989 {published data only}
Freeman BJC, Atherton WG, Howard PW, Burke FD. External
fixation or manipulation and plaster for severely displaced
comminuted Colles’ fractures? [Abstract]. Journal of Bone and Joint
Surgery - British Volume 1998;80 Suppl 1:53.
Freeman BJC, Atherton WG, Howard PW, Burke FD. External
fixation or manipulation and plaster for severely displaced
comminuted Colles’ fractures? [Abstract]. Journal of Bone and Joint
Surgery - British Volume 2000;82 Suppl 2:171.
∗
Howard PW, Stewart HD, Hind RE, Burke FD. External fixation
or plaster for severely displaced comminuted Colles’ fractures? A
prospective study of anatomical and functional results. Journal of
Bone and Joint Surgery - British Volume 1989;71(1):68–73.
Jenkins 1989 {published and unpublished data}
∗
Jenkins NH. The treatment of Colles’ fracture [Masters thesis:
Winner of Robert Jones Gold Medal and Association Prize 1989].
London: British Orthopaedic Association, 1988.
Jenkins NH, Jones DG, Johnson SR, Mintowt-Czyz WJ. External
fixation of Colles’ fractures. An anatomical study. Journal of Bone
and Joint Surgery - British Volume 1987;69(2):207–11.
Jenkins NH, Jones DG, Mintowt-Czyz WJ. External fixation and
recovery of function following fractures of the distal radius in
young adults. Injury 1988;19(4):235–8.
Jenkins NH, Jones DG, Mintowt-Czyz WJ. The role of external
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Kapoor 2000 {published data only}
Kapoor H, Agarwal A, Dhaon BK. Displaced intra-articular
fractures of distal radius: a comparative evaluation of results
following closed reduction, external fixation and open reduction
with internal fixation. Injury 2000;31(2):75–9.
Kreder 2006 {published and unpublished data}
Agel J. personal communication October 10 2006.
Cebesoy O, Isik M. Is external fixation necessary for distal radius
fracture without joint incongruity? [letter]. Journal of Orthopaedic
Trauma 2006;20(5):374.
∗
Kreder HJ, Agel J, McKee MD, Schemitsch EH, Stephen D,
Hanel DP. A randomized, controlled trial of distal radius fractures
with metaphyseal displacement but without joint incongruity:
25
closed reduction and casting versus closed reduction, spanning
external fixation, and optional percutaneous K-wires. Journal of
Orthopaedic Trauma 2006;20(2):115–21.
Kreder HJ, Hanel DP, Agel J, McKee MD. A randomized
controlled trial of closed reduction and casting versus closed
reduction and external fixation for distal radius fractures with
metaphyseal displacement but without joint incongruity [Abstract].
American Society for Surgery of the Hand 57th Annual Meeting;
2002 Oct 3-5; Phoenix, AZ. 2002.
Kreder HJ, Hanel DP, Agel J, McKee MD, Trumble TE. A
randomized controlled trial of closed reduction and casting versus
closed reduction and external fixation for distal radius fractures
with metaphyseal displacement but without joint incongruity
[Abstract]. Orthopaedic Trauma Association Annual Meeting;
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ota/am/ota02/otapa/OTA02065.htm (accessed 01/11/02).
Lagerstrom 1999 {published data only}
Lagerstrom C, Nordgren B, Olerud C. Evaluation of grip strength
measurements after Colles’ fracture: a methodological study.
Scandinavian Journal of Rehabilitation Medicine 1999;31(1):49–54.
∗
Lagerstrom C, Nordgren B, Rahme H. Recovery of isometric grip
strength after Colles’ fracture: a prospective two-year study.
Scandinavian Journal of Rehabilitation Medicine 1999;31(1):55–62.
McQueen 1996 {published data only}
McQueen MM, Court-Brown CM. Unstable fractures of the distal
radius: a prospective randomized comparison of four treatment
methods [Abstract]. Orthopaedic Transactions 1997;21(2):595–6.
∗
McQueen MM, Hajducka C, Court-Brown CM. Redisplaced
unstable fractures of the distal radius. A prospective randomised
comparison of four methods of treatment. Journal of Bone and Joint
Surgery - British Volume 1996;78(3):404–9.
Pring 1988 {published data only}
∗
Pring DJ, Barber L, Williams DJ. Bipolar fixation of fractures of
the distal end of the radius: a comparative study. Injury 1988;19
(3):145–8.
Pring DJ, Williams DJ. Bipolar fixation of fractures of the distal
radius: a comparative study [Abstract]. Journal of Bone and Joint
Surgery - British Volume 1986;68(4):666.
Rodriguez-Merchan 92 {published data only}
Merchan EC, Breton AF, Galindo E, Peinado JF, Beltran J. Plaster
cast versus Clyburn external fixation for fractures of the distal radius
in patients under 45 years of age. Orthopaedic Review 1992;21(10):
1203–9.
Roumen 1991 {published data only}
Roumen RM, Hesp WL, Bruggink ED. Unstable Colles’ fractures
in elderly patients. A randomised trial of external fixation for
redisplacement. Journal of Bone and Joint Surgery - British Volume
1991;73(2):307–11.
Stein 1990 {published data only}
Stein H, Volpin G, Horesh Z, Hoerer D. Cast or external fixation
for fracture of the distal radius. A prospective study of 126 cases.
Acta Orthopaedica Scandinavica 1990;61(5):453–6.
Young 2003 {published and unpublished data}
Nanu AM, Pappasaras S, Rangan A, Checketts RG. Plaster cast vs
the Pennig dynamic fixator for Colles’ fracture - a prospective
randomised trial [Abstract]. Journal of Bone and Joint Surgery British Volume 1994;76 Suppl 2 & 3:149.
Young CF. personal communication April 21 2002.
Young CF. personal communication August 18 2002.
Young CF, Nanu AM, Checketts RG. Plaster immobilisation versus
Pennig external fixator for distal radius fractures [Abstract]. Journal
of Bone and Joint Surgery - British Volume 2000;82 Suppl 1:83.
Young CF, Nanu AM, Checketts RG. Plaster immobilisation versus
Pennig external fixator for distal radius fractures [Abstract].
Presentation at the The Third Orthofix Riva Congress; 2000 May
10-14; Riva del Garda, Italy 2000.
∗
Young CF, Nanu AM, Checketts RG. Seven-year outcome
following Colles’ type distal radial fracture. A comparison of two
treatment methods. Journal of Hand Surgery - British Volume 2003;
28(5):422–6.
Young CF, Nanu AM, Checketts RG. Seven year outcome study of
Colles’ type distal radial fractures [Abstract]. Journal of Bone and
Joint Surgery - British Volume 2003;85(Suppl 1):27.
Young CF, Nanu AM, Checketts RG. Seven year outcome study of
Colles’ type distal radial fractures [Abstract]. Presentation at the
The Third Orthofix Riva Congress; 2000 May 10-14; Riva del
Garda, Italy 2000.
Zheng 2003 {published data only}
Zheng HL, Wu F, Guo T, Cai J, Zhang Y. [A comparison of
conservative and surgical treatment of distal radius unstable
fracture]. Journal of Clinical Orthopaedics 2003;6(3):211–3.
References to studies excluded from this review
Christensen 2001 {published data only}
Christensen OM, Christiansen TC, Krasheninnikoff M, Lind B,
Holmich LR, Hansen FF, et al.Plaster cast compared with bridging
external fixation for distal radius fractures of the Colles’ type.
International Orthopaedics 2001;24(6):358–60.
Kongsholm 1989 {published data only}
∗
Kongsholm J, Olerud C. Plaster cast versus external fixation for
unstable intraarticular Colles’ fractures. Clinical Orthopaedics and
Related Research 1989;(241):57–65.
Olerud C, Kongsholm J. External fixation of comminuted Colles’
fractures gives better results than conservative treatment. Zeitschrift
fur Unfallchirurgie, Versicherungsmedizin und Berufskrankheiten
1989;82(2):99–105.
Solgaard 1989 {published data only}
Solgaard S, Bunger C, Solund K. Displaced distal radius fractures.
A comparative study of early results following external fixation,
functional bracing in supination, or dorsal plaster immobilization.
Archives of Orthopaedic and Trauma Surgery 1989;109(1):34–8.
Sprenger 1988 {published and unpublished data}
Sennwald G. personal communication August 1 2002.
∗
Sprenger FB, Sennwald G, Weber BG. Therapy of the Colles
fracture with external fixative [Abstract] [Die therapie der
Colles–fraktur mit fixateur externe]. Hefte zur Unfallheilkunde
1988;200:300.
van Dijk 1996 {published data only}
Van Dijk JP, Laudy FG. Dynamic external fixation versus nonoperative treatment of severe distal radial fractures. Injury 1996;27
(1):57–61.
26
References to studies awaiting assessment
Moroni 2004 {published data only}
Moroni A, Vannini F, Faldini C, Pegreffi F, Giannini S. Cast vs
external fixation: a comparative study in elderly osteoporotic distal
radial fracture patients. Scandinavian Journal of Surgery 2004;93
(1):64–7.
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∗
Indicates the major publication for the study
29
CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]
Abbaszadegan 1990
Methods
Method of randomisation not stated
Assessor blinding: not reported
Intention-to-treat analysis: possible (5 in POP group analysed separately but data given)
Loss to follow up: 1 died in Ext-fix group
Participants
Teaching hospital, Sweden
47 participants
Inclusion criteria: “severely displaced Colles’ fracture”, displaced (= or > 5 mm radial shortening) distal
radial fracture (Older type 3 and 4), patient consent
Exclusion criteria: age > 75 years, addicts, mental incapacity, neuromuscular disturbance or warfarin
treatment
Classification: Older (type 3 and 4) (extra- and intra-articular)
Sex: 36 female
Age: mean 63 years; range 22 - 75 years
Assigned: 23/24 [Ext-fix / POP]
Assessed: 22/24 (at 1 year)
Interventions
Timing of intervention: not stated, but after X-ray examination
(1) External fixation: closed reduction under local anaesthesia, temporary dorsal plaster cast. External
Hoffman fixator applied at 1 to 3 days under regional anaesthesia: 2 pins inserted through 1 cm skin
incision through middle of second metacarpal and 2 pins in radius. Fixator removed at 4 weeks (mean 31
days)
(2) Conservative treatment: closed manipulation under local anaesthesia, then below elbow plaster cast
for 4 weeks (mean 31 days)
Outcomes
Length of follow up: 1 year; also assessed at 10-12 days, 4, 8, 12 and 24 weeks.
(1) Functional: subjective function (VAS: 0 to 10: normal), overall grading (Lidstrom 1959) including
activities of daily living, pain, loss of motion and deformity. Pain (VAS 0 to 10: worst), grip strength,
range of movement (flexion, extension, radial deviation, ulnar deviation, forearm rotation).
(2) Clinical: complications: redislocation resulting in secondary external fixation, pin track infection (all
resolved), osteomyelitis (none), pin loosening (none), transient sensory disturbance of the superficial radial
nerve.
(3) Anatomical: X-ray initially, at reduction, after 10-12 days, 4 and 8 weeks. Radial shortening and dorsal
angulation.
Notes
Five in plaster group required remanipulation and had external fixation. Separate data were provided for
this group.
Risk of bias
Item
Authors’ judgement
Description
Allocation concealment?
Unclear
B - Unclear
30
Hegeman 2004
Methods
Randomised by random selection of envelopes containing a piece of paper with the treatment allocation
Intention-to-treat analysis: likely
Loss to follow up: probably none
Participants
Teaching hospital, The Netherlands
32 participants
Inclusion criteria: unstable intra-articular distal radial fracture (> 10 degrees dorsal angulation and < 20
degrees radial inclination and > 3 mm positive ulnar variance) (AO C2 or C3). Age 55 to 80 years.
Exclusion criteria: previous distal radial fracture or unable to perform functional evaluation
Classification: AO (type C2 or C3) (all intra-articular)
Sex: 29 female
Age: mean 70 years
Interventions
Timing of intervention: not stated, but after X-ray examination
(1) External fixation: reduction then application of Hoffmann II compact external fixator: 2 pins inserted
into the second metacarpal and 2 pins in radial shaft. Fixator removed after 6 weeks
(2) Conservative treatment: closed manipulation then below elbow plaster cast for 6 weeks
Physiotherapy started after 6 weeks.
Outcomes
Length of follow up: 1 year; also assessed at 6 weeks, and 3 and 6 months.
(1) Functional: problems in daily life (lifting cup, wringing, fine hand co-ordination, heavy load bearing),
overall grading (Gartland 1951) including subjective evaluation of impairment, range of motion, residual
deformity and complications. Pain (in joints), grip strength (hand and index finger), range of movement
(flexion, extension, radial deviation, ulnar deviation, pronation, supination).
(2) Clinical: complications: “complications of plaster immobilisation” (loose plaster; swollen thumb), pin
track infection, transient neuropraxia, RSD, Dupuytren contracture. Deformity: prominent dinner fork
deformity, radial deviation of hand.
(3) Anatomical: X-ray initially, after treatment, and all follow-up times. Radial shortening, radial inclination, dorsal angulation, ulnar variance. Intra-articular alignment: step off.
Notes
Details on method of randomisation and plaster cast complications received from Dr Hegeman on 10
October 2006.
Risk of bias
Item
Description
Unclear
B - Unclear
31
Horne 1990
Methods
Intention-to-treat analysis: no, baseline information or interim results not given for 8 participants; discrepancies in numbers followed in the two groups
Loss to follow up: 5 lost and 3 dead by final follow up (4 to 15 months)
Participants
Teaching hospital, New Zealand
37 participants
Inclusion criteria: displaced fractures of the distal radius judged as requiring reduction by resident on call.
Age > 60 years. Informed consent. (Implied Colles’ fractures.)
Exclusion criteria: none stated
Classification: Frykman (included Frykman 1, 2, 3, 4, 5 and 8) (extra- and intra-articular)
Sex: not given
Age: of 29 analysed, mean 72 years, range 61 - 91 years
Assigned: ?/? [Ext-fix / POP]
Assessed: 15/14 or 16/13 (see notes) (at final follow up 4-15 months)
Interventions
Timing of intervention: not stated but after presentation at fracture clinic; patients in the surgical group
were admitted to a day-care facility.
(1) External fixation: closed reduction under ischaemic arm block then modified AO tubular external
fixator for 5 weeks: 2 pins placed at right angles in 2nd metacarpal, 2 pins placed at right angles into
dorsoradial aspect of distal radius. “Stab incisions” of pins.
(2) Conservative treatment: closed reduction under ischaemic arm block then below-elbow backslab, 1015 degrees palmar flexion and ulnar deviation, for 5 weeks.
Physiotherapy afterwards if wrist or hand stiffness.
Outcomes
Length of follow up: 4 to 15 months; also assessed at 1 and 5 weeks.
(1) Functional: overall grading (not referenced but seems to be Stewart 1985, modification of Gartland
1951) including subjective (pain, disability, activity restriction, movement limitation) and objective (range
of movement, finger flexion, grip strength, radial/median neuritis) measures.
(2) Clinical: complications: remanipulation (none), pin track problems (21%), radial nerve neuritis (26%),
RSD (none)
(3) Anatomical: X-ray initially, at reduction, and final follow-up. Dorsal displacement and radial displacement (Van der Linden 1981).
Notes
Abstract (Devane 1988) gives an inconsistent report of trial: 34 patients, minimum 6 months followup, some correlation between radiological result and functional outcome, external fixation group held
reduction significantly better, no mention of radial nerve irritation.
Highly critical letter from Axelrod 1991. Comments on entry criteria (how displaced were the fractures?),
length of follow up, advised small open incisions instead of percutaneous pinning. Response from Horne
did not address these issues.
Numbers at final follow up in each group varied in the main trial report (15/14 or 16/13).
The two measures of displacement: dorsal displacement and radial displacement (Van der Linden 1981)
are not in common use and prevent comparison with other trials.
Risk of bias
Item
Description
32
Horne 1990
(Continued)
Unclear
B - Unclear
Howard 1989
Methods
Assessor blinding: not reported; independent assessment of functional and 10 year radiological outcome
Loss to follow up: 6 (or 7) lost and 4 dead at 10 years
Participants
General hospital, UK
50 participants
Inclusion criteria: severely displaced (30 degrees of dorsal angulation or over 10 mm radial shortening)
comminuted Colles’ fracture
Exclusion criteria: age > 75 years
Classification: not stated (intra-articular definitely included)
Sex: not given (both sexes)
Age: mean 47 years
Assessed: 21/19 (or 21/18) (at 10 years)
Interventions
Timing of intervention: not stated, but probably soon after hospital admission; surgery was usually done
on the next available trauma list. (1) External fixation: medium-C Hoffman external fixator: 2 pins inserted
into middle of 2nd and 3rd metacarpals, 2 into radial shaft. Fixator locked after reduction (under image
intensifier). Removed after 5 to 6 weeks.
(2) Conservative treatment: closed manipulation under Bier’s block and below-elbow backslab, completed
next day (remanipulation if initial reduction was unsatisfactory). Plaster cast for 5 to 6 weeks.
All had physiotherapy afterwards.
Outcomes
Length of follow up: 10 years (mean 10.25 years); also assessed at 1, 2, 5 and 13 weeks and 6 months.
(1) Functional: overall grading (Gartland 1951; Stewart 1984) including subjective (pain, disability,
activity restriction, movement limitation) and objective (range of movement, finger flexion, grip strength,
radial/median neuritis) measures.
(2) Clinical: complications: remanipulation, fixator distraction increased, pin track infection, radial nerve
neuritis, Sudeck’s atrophy (none), tendon (EPL) rupture, median nerve compression, ulnar nerve compression, osteoarthritis. Cosmetic appearance, patient satisfaction, osteoarthritis
(3) Anatomical: X-ray initially, at reduction, and all follow-up times. Dorsal angulation, radial shift, radial
shortening and radial deviation. Overall anatomical score (Stewart 1984), radiological deformity (Dias
1987), arthritis (Knirk and Jupiter 1986)
Notes
Anatomical results presented graphically in main paper.
10 years follow up reported in two separate abstracts (Freeman 1998; Freeman 2000).
Slight discrepancies between the two abstracts in the numbers lost to follow up at 10 years and final
functional result for the fixation group.
Risk of bias
Item
Description
33
Howard 1989
(Continued)
Unclear
B - Unclear
Jenkins 1989
Methods
Randomised by date of birth
Assessor blinding: not done
Intention-to-treat analysis: problems including disparities in reported inclusion criteria and 24 excluded
from analyses, including 17 with follow up < 12 months after fracture union, 3 allocated external fixation
(2 had premature removal of fixator due to recurrent infections and 1 had an iatrogenic radial shaft
fracture) and 4 allocated plaster casts who were given external fixation after remanipulation.
Loss to follow up: 29 (including 24 exclusions)
Participants
Teaching hospital, UK
153 participants
Inclusion criteria: displaced distal radial fracture (Colles’ fractures) requiring manipulation, unilateral, age
< 65 years (or < 60 years in journal publications: see Notes)
Exclusion criteria: radiographic evidence of osteoporosis
Classification: Frykman (extra- and intra-articular)
Sex: not given
Age: mean 44 years
Assessed: 68/56 (13+ months)
Interventions
Timing of intervention: probably reduction at fracture clinic, external fixation on day of injury or next
day.
(1) External fixation: closed reduction and usually overnight hospital admission (tended to be day cases
later on in trial) for AO/ASIF external mini-fixator (in ’Z’ or box configuration) application under general
anaesthesia. Two proximal Kirschner wires at right angles into radial shaft (stab incisions) and 2 distal
wires at right angles transfixed comminuted distal fragments. Insertion under image intensified using a
power drill. Wrist usually mobile but no physiotherapy. Fixator removed after 4 weeks.
(2) Conservative treatment: closed manipulation under intravenous sedation, then dorsal plaster slab,
completed at 1 week. Cast removed after 4 weeks. Crepe bandage and mobilisation.
Immobilisation increased by one week if non-union at 4 weeks.
There was no formal physiotherapy.
Outcomes
Length of follow up: 13 months (12 months after union); also assessed at 1 and 4 weeks and 2 and 4
months.
(1) Functional: range of movement (flexion, extension, radial and ulnar deviation, pronation, supination)
, mass grip strength. Overall grading (Stewart 1985, modification of Sarmiento) including subjective and
objective outcomes.
(2) Clinical: complications (* = no data given for POP group): remanipulation (4 in POP group in Masters
thesis but 6 in 1988 report), pin track infection, serious infection (recurrent and deep), osteomyelitis,
premature frame removal, pin site fracture (radial shaft), median nerve compression (none), sensory
changes in superficial radial nerve (11 of which 2 permanent in Ext-fix group), ulnar nerve problems
(none), unstable distal radial-ulnar joint restricting supination* (2 of 3 had reconstructive surgery, RSD
(2/24 of the POP group had shoulder-hand syndrome in the 1987 report)
(3) Anatomical: measured at post reduction, union (4 weeks), and 1 and 13 months post union. Dorsal
angulation, radial shortening, radial length. Overall and changes in anatomical grading (Stewart 1985)
34
Jenkins 1989
(Continued)
Notes
Initially, in the first version of the overall review, this trial was reported as 2 trials: Jenkins 1987 and Jenkins
1988. Similarities were noted and we suggested that there may be shared patients. This was confirmed on
communication with the lead trialist who indicated that these were both “pilot studies” in an overall larger
study which formed his Masters thesis. In Handoll 2003a, the results presented in this thesis replaced
those presented previously.
There were several inconsistencies noted between the various trial reports. One is that the upper age limit
was stated to be 60 years in the journal publications and 65 years in the thesis. Another is that there were 6
remanipulations in the POP group registered in the 1988 report but only 4 (all leading to external fixation
and subsequent exclusion from the analyses) in the thesis.
It is likely that the date of last follow up was set up as at least 12 months from union, rather than exactly
12 months from union, and some participants may have been followed up for 3 years.
Risk of bias
Item
Description
No
C - Inadequate
Kapoor 2000
Methods
Intention-to-treat analysis: not known, loss to follow up deduced from paper
Loss to follow up: 20 (at 4 years)
Participants
Teaching hospital, India
61 participants (in review comparison: see Notes)
Inclusion criteria: acute displaced intra-articular distal radius fracture, adult. Dorsal or volar displacement.
Exclusion criteria: not given
Classification: Frykman 3, 4, 7 & 8 (and AO) (intra-articular)
Sex: 15 female
Age: mean 39 years (of 90)
Assessed: 18/23 (at 4 years)
Interventions
Timing of intervention: not stated, but acute injury.
(1) External fixation: Roger and Anderson external frame fixator: 2 pins into 2nd and 3rd metacarpals,
2 into radius shaft. Patients encouraged to use limb (eating etc) and rotate forearm. Fixator removed 6-7
weeks. Splint for 2 days after removal of fixator, then mobilisation.
(2) Conservative treatment: closed reduction and plaster cast. Remanipulated once if necessary. Immobilisation for 6 to 7 weeks.
Outcomes
Length of follow up: average 4 years; also assessed at 1 week and 6 to 7 weeks (certainly Ext-fix and POP
groups).
(1) Functional: overall grading (Sarmiento 1975) including subjective evaluation, objective evaluation,
residual deformity, and complications. Range of movement (flexion, extension, radial deviation, ulnar
deviation, pronation, supination).
(2) Clinical: complications: redisplacement (not enumerated), pin track infection, CTS (resolved), finger
35
Kapoor 2000
(Continued)
stiffness (all resolved), RSD (resolved). Residual cosmetic deformity
(3) Anatomical: X-ray at reduction, and probably other times (see above). Radial shortening, dorsal tilt,
volar angulation, articular step off. Overall grading (no reference)
Notes
Trial with 90 participants had 3 intervention groups. Excluded from this review are the 29 participants
receiving open reduction and internal fixation using Kirschner wires, small T-plates or both.
70% of the whole trial population had fractures resulting from a road traffic accident.
Discrepancies between functional grading in Table 2 and account in report abstract.
Risk of bias
Item
Description
Unclear
B - Unclear
Kreder 2006
Methods
Randomised by sealed opaque sequentially marked envelopes based on computer-generated random number sequences
Assessor blinding: no (although independent research assistants)
Loss to follow up: 28
Participants
3 teaching hospitals, Canada
113 participants
Inclusion criteria: displaced distal radial fracture with metaphyseal comminution but without joint incongruity. Skeletally mature, aged 16 to 75 years. Stable congruous joint. Patient consent.
Exclusion criteria: comminution > 1/3rd the anterior-posterior diameter of radius, dorsal tilt > 10 degrees,
detectable step or gap at joint surface, history of previous wrist fracture, congenital anomaly or other
severe wrist problem, not fit for surgery, definitive treatment could not be administered within 1 week,
mentally incompetent, unable to write in English. Open fracture, associated ipsilateral extremity injuries,
other significant system injuries.
Classification: AO (extra- and intra-articular)
Sex: 74 female
Age: mean 53 years
Interventions
Timing of intervention: within 1 week of injury.
(1) External fixation: closed reduction under regional anaesthesia. Application of the small spanning AO
fixator: 2.5 mm pins into 2nd metacarpal and 4 mm pins into radius via 1 cm skin incision. Additional
(in 19 cases) smooth Kirchner wires inserted from the radial styloid or dorsum of the radius across the
fracture fragments at surgeon’s discretion. Optional wires removed 4 to 6 weeks. Fixator removed between
6 to 8 weeks.
(2) Conservative treatment: closed reduction under haematoma block (and fluoroscopy), then long arm
splint with wrist in neutral and elbow at 90 degrees - reduction repeated if necessary. Splint converted to
long arm cast within 14 days, reduced to short arm cast at 3 to 4 weeks, removed 6 to 8 weeks.
Finger exercises during fixator or cast use, and wrist exercises post immobilisation. All participants received
36
Kreder 2006
(Continued)
supervised physiotherapy [until maximum range of motion was achieved].
Outcomes
Length of follow up: 2 years; also assessed at 1, 2, 3, 4 and 6 weeks, and 6 and 12 months.
(1) Functional: Musculoskeletal Function Assessment (upper extremity) and SF-36 (bodily pain domain)
questionnaires. Job change because of injury. Jebsen Taylor hand function (Jebsen 1969); grip, pinch, pad
and chuck strengths; range of movement (flexion, extension, radial deviation, ulnar deviation, pronation,
supination).
(2) Clinical: complications: secondary treatment resulting from redisplacement (open reduction and
internal fixation for I Ext-fix and external fixation for 5 POP); distal radial ulnar joint instability (one
Ext-fix had ulnar styloid repair), pin track infection, superficial infection, deep infection, RSD.
(3) Anatomical: X-ray at reduction, and other times up to 6 months (see above). Union, radial shortening
and palmar tilt restoration.
Notes
Further details of method of randomisation and rehabilitation received from Julie Agel on 10 October
2006.
Some percentages in Table 1 in the trial report giving baseline data and results did not correspond to
stated numbers available at baseline or at follow up times.
Risk of bias
Item
Description
Yes
A - Adequate
Lagerstrom 1999
Methods
Randomised using computer, “within 6 unit blocks”
Intention-to-treat analysis: problems including 2 exclusions. Five in POP group who received secondary
external fixation were analysed separately; data from the 5 males in the Ext-fix group also remove from
the analyses of grip strength
Loss to follow up: 2 (excluded)
Participants
Teaching hospital, Sweden
35 participants
Inclusion criteria: displaced (3+ mm radial shortening; 10+ degrees dorsal or 10+ degrees radial angulation
of the radius) distal intra-articular Colles’ fracture involving distal radio-ulnar joint. Age 45 to 75 years.
Feasible to use plaster cast or external fixator
Exclusion criteria: medical conditions or language difficulties that might interfere with outcome.
Classification: Frykman (5 to 8) (intra-articular)
Sex: 30 female
Age: mean 58 years; range 45 - 72 years (of 33)
Interventions
Timing of intervention: not stated. No mention of method of reduction.
(1) External fixation: light (in weight) non-cylindrical AO external fixator. Immobilised for 6 weeks.
(2) Conservative treatment: cylindrical below elbow plaster cast for 6 weeks.
37
Lagerstrom 1999
(Continued)
Physiotherapy started soon (same day or next day) after fracture had been immobilised, in both groups.
Outcomes
Length of follow up: 2 years; also assessed at up to 10 days, 6, 10 and 18 weeks and 1 year.
(1) Functional: grip strength, and pain during grip measurements.
(2) Clinical: complications:
redisplacement requiring treatment change, refracture.
(3) Anatomical: no information. Redisplacement with 10 days.
Notes
Five in POP group required remanipulation and had external fixation. This group was analysed separately.
Separate analyses were also undertaken for the 5 male patients, all in the external fixation group.
Risk of bias
Item
Description
Unclear
B - Unclear
McQueen 1996
Methods
Randomised by closed envelopes
Loss to follow up: 8 (at 1 year)
Participants
Teaching hospital, UK
90 participants (in review comparison: see Notes)
Inclusion criteria: redisplaced unstable distal radial fracture (redisplaced to >10 degrees dorsal angulation
or radial shortening > 3 mm)
Exclusion criteria: inadequate primary reduction, > 2 weeks from injury to recognised instability, displaced
articular fragments requiring open reduction, previous malunion, mental incapacity
Classification: AO (A and C) (extra-articular and intra-articular)
Sex: 81 female
Age: mean 63 years, range 16 - 86 years (of 120 patients)
Assigned: 30/30/30 [Ext-fix / Ext-fix with early mobilisation / POP]
Assessed: 28/26/28 (at 1 year)
Interventions
Timing of intervention: under 2 weeks from injury
(1) External fixation: closed reduction and Pennig external fixator. Two pins inserted into 2nd metacarpal
and 2 into radial shaft using an open technique. Ball joint locked. Fixator removed after 6 weeks.
(2) External fixation: as above (1) but release of ball joint of fixator at 3 weeks to allow wrist movement.
(3) Conservative treatment: closed manipulation, then forearm cast for 6 weeks.
Physiotherapy prescribed on “purely clinical grounds”. Patients did not receive physiotherapy when the
fixator was in place.
Outcomes
Length of follow up: 1 year; also assessed at 6 weeks, 3 and 6 months.
(1) Functional: activities of daily living (own scale), mass grip strength, other grips, pain (VAS 0 to 10:
no data), range of movement (overall, flexion and extension).
(2) Clinical: complications: recurrent instability, malunion, pin track infection, RSD, CTS, dorsal medial
38
McQueen 1996
(Continued)
neuropraxia (superficial radial nerve?), EPL rupture (none), carpal collapse.
(3) Anatomical: X-ray at all follow-up times. Dorsal angulation, radial shortening, carpal malalignment,
malunion.
Notes
Trial with 120 participants had 4 intervention groups. Excluded from this review are the 30 participants
receiving open reduction and bone graft held in place with a single Kirschner wire.
Risk of bias
Item
Description
Unclear
B - Unclear
Pring 1988
Methods
Assessor blinding: not reported, two assessors worked independently of each other
Intention-to-treat analysis: No, the results from 9 people allocated plaster cast but treated with external
fixation after redisplacement were stated as being put into a separate group for “purposes of analysis”.
They were presented in the surgical group for surgical complications.
Loss to follow up: 9 (at 6 months)
Participants
District general hospital, UK
75 participants with 76 fractures
Inclusion criteria: Colles’ fracture, displaced distal radius fracture
Exclusion criteria: not stated
Classification: extra- and intra-articular
Sex: 61 female
Age: mean 62 years
Assigned: 36/39 (40 fractures) [Ext-fix / POP]
Assessed: ?/? (66 available at 6 months)
Interventions
Timing of intervention: not stated, but at accident and emergency department after closed reduction via
traction using finger traps under a haematoma block
(1) External fixation: “bipolar fixation”. Two half pins inserted percutaneously into the radial shaft and
secured in both cortices and one pin through the thumb metacarpal at 90 degrees to the radial pins. Pins
incorporated into a padded forearm cast with wrist in neutral position.
(2) Conservative treatment: plaster of Paris forearm cast applied under traction with wrist in neutral
position and forearm pronated.
In both groups, the completed casts were split down the ulnar border. Early hand function was encouraged.
If necessary, participants attended a daily hand class before and after cast removal, which was after 5 weeks.
Outcomes
Length of follow up: 6 months; also assessed at 1, 2, 5, 7 and 12 weeks.
(1) Functional: overall grading (Scheck 1962: based on Gartland 1951) included subjective evaluation,
wrist appearance, wrist and finger movements, grip, radiological assessment. Grip strength.
(2) Clinical: complications: redisplacement (all in POP group treated with external fixation). All those
(45) who had external fixation including 9 people allocated POP: thumb pain (9 ), migrated pin (1),
fracture through pin hole (1), pin loosening or infection (7)
39
Pring 1988
(Continued)
(3) Anatomical: X-ray at reduction, 1, 2, 5 and 12 weeks. Radial length, volar angle, radial angle.
Notes
Preliminary results presented at a conference (Pring 1986) were for 51 participants.
Risk of bias
Item
Description
Unclear
B - Unclear
Methods
Method of randomisation not stated, claimed to be “double-blind”
Assessor blinding: not stated
Loss to follow up: probably none
Participants
Teaching hospital, Spain
70 participants
Inclusion criteria: comminuted intra-articular distal radial fracture, Frykman 3 to 8
Exclusion criteria: > 45 years
Classification: Frykman (3 to 8) (intra-articular)
Sex: 12 female
Assessed: 35/35 (1 year)
Interventions
Timing of intervention: probably reduction on first day, external fixation on first or next day.
(1) External fixation: reduction under general anaesthesia or brachial block. Clyburn dynamic external
fixator: 2 pins driven into radial diaphysis and 2 into diaphysis of 2nd metacarpal. Overnight hospital
admission. Posterior splint applied for 3 weeks if joint disrupted; transverse pin inserted for 3 weeks if
joint unstable. Device removed after 7 weeks. Pin sites dressed by medical staff at weekly intervals
(2) Conservative treatment: closed manipulation under local anaesthesia, then forearm plaster. Remanipulation at 1 week if position unacceptable. Total 7 weeks, unless problems when kept for 1 more week.
Before discharge, patients were given instructions to mobilise fingers and shoulder.
Outcomes
Length of follow up: 1 year; also assessed at 1, 3 and 7 weeks.
(1) Functional: overall grading (Horne 1990, thus probably based on Stewart 1985) based on subjective
and objective outcomes.
(2) Clinical: complications: remanipulation (offered), pin track infection, pin loosening, premature frame
removal (none), joint infection (none), osteomyelitis (none), pin breakage (none), RSD (Sudeck’s atrophy
requiring intensive physiotherapy), tendon or nerve injuries (none), non-union (none)
(3) Anatomical: X-ray at 1, 3 and 7 weeks. Dorsal angulation, radial shortening, radial length. Overall
grade (Stewart 1985 based on Lidstrom 1959 and Sarmiento 1975)
Notes
First author listed as Merchan ECR in article. Journal is now American Journal of Orthopedics.
Risk of bias
40
(Continued)
Item
Description
Unclear
B - Unclear
Roumen 1991
Methods
Intention-to-treat analysis: not known, but some of the 19 patients who had died (2) or were lost to follow
up (17) from the original study group may have belonged to the randomised trial.
Lost to follow up: not known - see above
Participants
General hospital, The Netherlands
43 participants followed up
Inclusion criteria: redisplaced Colles’ fracture with dorsal angulation > 10 degrees or radial shortening >
5 mm. Age > 55 years (all intra-articular)
Exclusion criteria: not stated
Classification: Frykman and Sarmiento (intra-articular)
Sex: not given (predominantly female)
Age: not given, > 55 years
Assigned: ?/? reported 21/22 [Ext-fix / POP]
Assessed: 21/22 (6 months)
Interventions
Timing of intervention: all patients had initial fracture reduced, within 6 hours of injury, under local
anaesthesia and treated with plaster backslab, which we assume was completed to a forearm plaster cast.
Seen 1, 7 and 14 days. Allocation at 2 weeks if fracture redisplaced (see inclusion criteria).
(1) External fixation: fracture remanipulated under regional anaesthesia and Ace Colles external fixator
applied for 5 weeks
(2) Conservative treatment: forearm plaster cast continued for a further 5 weeks
Outcomes
Length of follow up: 6 months; also assessed post manipulation and 5 weeks on removal of plaster cast or
fixator.
(1) Functional: overall grading by de Bruijn 1987 and Lidstrom 1959 systems, pain (at rest, on movement,
on ulnar pressure), grip strength.
(2) Clinical: complications: pin loosening, pin track infection (none), RSD (serious RSD: 2/1), CTS (no
data), tenosynovitis (no data), EPL rupture. Cosmetic appearance: specially not noted.
(3) Anatomical: X-ray post re-MUA and on removal of plaster cast or external fixator. Overall grading
Lidstrom 1959 and Sarmiento 1980. Also volar angle, radial shortening, radial angle and radial shift.
Notes
A third group of patients who did not have redisplacement at 2 weeks were also followed up.
Risk of bias
Item
Description
Unclear
B - Unclear
41
Stein 1990
Methods
Randomised by day of hospital admission
Intention-to-treat analysis: not known
Lost to follow up: not stated, perhaps none
Participants
Teaching hospital, Israel
62 participants
Inclusion criteria: displaced comminuted distal radial fracture (Older type 3 and 4: Colles’ fracture).
Shortening of distal radius 1 to 4 mm below distal ulna (Older type 3) or greater.
Classification: Older (type 3 and 4) (all intra-articular)
Sex: not given
Assessed: 40/22
Interventions
Timing of intervention: not stated but after presentation at fracture clinic; participants of the surgical
group were either admitted into hospital for 24 hours or to a day-care facility. Fractures reduced under
regional or general anaesthesia.
(1) External fixation: closed reduction then the “small” AO external tubular fixator, usually for 6 weeks:
2 pins placed in 2nd metacarpal, 2 pins placed into radial shaft.
(2) Conservative treatment: closed reduction then above-elbow plaster cast with the forearm in pronation,
usually for 6 weeks.
Outcomes
Length of follow up: 6 months to 4 years (mean 3 years); also assessed at 1, 2, 4 and 6 weeks.
(1) Functional: overall grading split by subjective (pain, deformity, grip strength, inability to return to
previous activities) and objective results using Gartland 1951.
(2) Clinical: complications: remanipulation,
pin track infection (all resolved), pin loosening, breakage (none), osteomyelitis (none), superficial radial
nerve irritation (temporary), RSD
(3) Anatomical: X-ray initially and at all follow-up times. Dorsal angulation, radial shortening, radial
angulation and shift. Overall grading of deformity (Van der Linden 1981).
Notes
Results for another 64 patients with extra-articular fractures were treated with an above-elbow plaster cast
were also presented in the trial report. However, these were not part of the trial.
Risk of bias
Item
Description
No
C - Inadequate
42
Young 2003
Methods
Randomised using closed envelopes
Assessor blinding: not reported (independent physiotherapist at 7 years)
Intention-to-treat analysis: losses accounted for. (Late decision to exclude data for a person with rheumatoid
arthritis)
Loss to follow up: 39 (at 7 years)
Participants
General hospital, UK
125 participants
Inclusion criteria: displaced Colles’ fracture, unilateral, dorsal angulation > 10 degrees, radial shortening
> 2 mm, age 16 - 75 years
Exclusion criteria: bilateral fracture, associated fractures of ipsilateral limb, die punch fractures, multiple
injuries, unable to understand purpose of study
Classification: Frykman (extra-articular and intra-articular)
Sex: 97 female
Assessed: 48/60 (at 1 year); 36/50 or 36/49 (at 7 years)
Interventions
Timing of intervention: not stated
(1) External fixation: manipulation and application of bridging Pennig dynamic fixator under general
anaesthesia. Pins inserted percutaneously into 2nd metacarpal and under direct vision into the radial shaft.
Distal ball joint unlocked at 3 weeks, fixator removed at 6 weeks
(2) Conservative treatment: manipulation under regional or general anaesthesia and application of below
elbow plaster backslab; then completed to full below-elbow plaster cast at 1 week and removed at 6 weeks
Outcomes
Length of follow up: 7 years (mean 7.8 years); also assessed at 1, 2, 6 and 9 weeks, 3, 6, 12 and 18 months
and 2 years.
(1) Functional: difficulties in two aspects of activities of daily living, grip strength, range of movement (
pronation, supination, flexion, extension, radial and ulnar deviation) from 9 weeks onwards. Use of wrist
splint. Persistent wrist pain (1 in conservative group had rheumatoid arthritis at 7 years). Time to return
to normal activities and work. Overall grades (Gartland 1951) at 7 years.
(2) Clinical: complications: redisplacement by 2 weeks, remanipulation, malunion, median nerve neuropathy, pin site infection (all superficial), radial nerve neuropathy, RSD (including 1 versus 3 persistent
at 1 year, and 1 versus 0 at 7 years), EPL tendon rupture, osteoarthritis (signs: just one with symptoms).
Patient satisfaction, unsightly forearm scars (from external fixator)
(3) Anatomical: X-ray initially, pre-operatively at reduction and all the above times. Radial shortening,
radial shift, radial and dorsal angulation. Malunion. Osteoarthritis (Knirk 1986)
Notes
The full publication of the 7 year results is new to this review and is the first full report of this trial previously
only reported in abstracts. The trial appeared as Young 2002 in Handoll 2003a, and as Nanu 1994 in
first version of that review. For Handoll 2003a, Miss Young provided copies of the drafts of 3 papers,
submitted for journal publication, and also provided answers to further queries. There are differences in
presentation between the draft and published reports of the 7 year results. These include the general use
of medians in the published report and the exclusion of data for one person with rheumatoid arthritis.
Risk of bias
Item
Description
43
Young 2003
(Continued)
Unclear
B - Unclear
Zheng 2003
Methods
Randomised by admission number
Intention-to-treat analysis: not known
Lost to follow up: not stated, probably none
Participants
Military (police) hospital, China
29 participants
Inclusion criteria: closed unstable distal radial fracture
Classification: Universal classification (Cooney) IIB, IIC (extra-articular), IVB, IVC (intra-articular)
Sex: 14 female
Age: range 18 - 52 years
Assigned: 12/17 (if none lost to follow up) [Ext-fix / POP]
Interventions
Timing of intervention: not stated. Participants were either outpatients or inpatients.
(1) External fixation: closed (5 participants) or open (7 participants) reduction under brachial plexus
block. Then application of small size Zhongjia SGD-type unilateral multifunctional external fixator:
2 pins inserted through skin incisions (0.7 cm) into the second metacarpal and 2 pins through skin
incisions in radial shaft. Kirschner wire added if fracture was still unstable. Wrist fixed in medial position,
slight extension and ulnar deviation or volar flexion (opposite to the direction of the injury). Fixator
made dynamic and K-wire removed from week 4. Fixator removed after 6 weeks. Immediate functional
training finger mobilisation; then, finger, elbow and shoulder from week 2; wrist joint mobilisation and
strengthening activities from week 4.
(2) Conservative treatment: manual reduction under haematoma block with X-ray monitoring. Plaster of
Paris short-arm (forearm) cast applied, position changed after 2 weeks to “medial”. Cast removed after 6
weeks. Functional training was done before and after removing the cast.
Outcomes
Length of follow up: 1 year; also assessed at 2 and 6 weeks.
(1) Functional: overall grading (Sarmiento 1975) including subjective evaluation of activity restriction
and pain, objective evaluation of function, range of motion (loss of flexion or extension rated) and grip
strength.
(2) Clinical: complications: loosened nail, injured superficial radial nerve, carpal tunnel syndrome.
(3) Anatomical: X-ray initially, after treatment, and all follow-up times. Anatomical assessment (Stewart
1984), radial shortening, volar angulation, ulnar angulation
Notes
Translated from Chinese by Xiaoyan Chen
Risk of bias
Item
Description
No
C - Inadequate
44
<: less than
>: more than
AO: Arbeitsgemeinschaft fur Osteosynthesefragen / Association for the Study of Internal Fixation (or ASIF)
CTS: carpal tunnel syndrome
DISI: dorsal intercalated segment instability
EPL: extensor pollicis longus (tendon)
Ext-fix: external fixation
hypoaesthesia: decrease in sensation
K-wires: Kirschner wires
paraesthesia: numbness, tingling, “pins and needles” sensation
POP: plaster of Paris
ROM: range of movement (wrist and forearm)
RSD: reflex sympathetic dystrophy
VAS: visual analogue scale
VISI: volar intercalated segment instability
X-pins: crossed percutaneous pinning
References (listed above but not in Additional references)
* de Bruijn 1987
de Bruijn HP. Functional treatment of Colles fracture. Acta Orthopaedica Scandinavica Supplementum 1987; 223:1-95.
*Dias 1987
Dias JJ, Wray CC, Jones JM, Gregg PJ. The value of early mobilisation in the treatment of Colles’ fractures. Journal of Bone & Joint
Surgery - British Volume 1987; 69(3):463-7.
* Lidstrom 1959
Lidstrom A. Fractures of the distal end of the radius. A clinical and statistical study of end results. Acta Orthopaedica Scandinavica
Supplementum 1959; 41:5-118.
*Sarmiento 1975
Sarmiento A, Pratt GW, Berry NC, Sinclair WF. Colles’ fractures. Functional bracing in supination. Journal of Bone & Joint Surgery
- American Volume 1975; 57(3):311-7.
*Sarmiento 1980
Sarmiento A, Zagorski JB, Sinclair WF. Functional bracing of Colles’ fractures: a prospective study of immobilization in supination vs.
pronation. Clinical Orthopaedics & Related Research 1980; 146:175-83.
Characteristics of excluded studies [ordered by study ID]
Christensen 2001
Not a randomised comparison. Compares treatment with external fixation at one hospital with plaster cast at
another hospital.
Kongsholm 1989
Not a randomised comparison. Use of historic controls.
Solgaard 1989
Includes patients from a randomised trial of conservative treatment but the patients in the external fixator group
were not randomised.
Sprenger 1988
Insufficient information to include. Quasi-randomised trial (60 participants) reported only in an abstract. (Superior radiological results were reported for the external fixator group). Though one trialist provided brief details
of the method of randomisation (alternation) and setting (emergency department), the likelihood of getting
further information or the trial ever being published seems remote.
van Dijk 1996
Retrospective comparison.
45
DATA AND ANALYSES
Comparison 1. External fixation versus plaster cast
Outcome or subgroup title
1 Functional grading: not excellent
2 Functional grading: not
excellent. Worst and best case
scenarios sensitivity analyses
2.1 Sensitivity analysis 1:
worst case for plaster cast
2.2 Sensitivity analysis 2: best
case for plaster cast
3 Functional grading: fair or poor
4 Subjective and objective
functional evaluation
4.1 Subjective grading: not
excellent
4.2 Subjective grading: fair/
poor
4.3 Objective grading: not
excellent
4.4 Objective grading: fair/
poor
5 Upper extremity function part
of Musculoskeletal Function
Assessment tool (0 to 100:
maximum disability)
5.1 At 6 months
5.2 At 1 year
5.3 At 2 years
6 Difficulties in activities of daily
living
6.1 Lifting cup at 3 months
6.2 Lifting cup at 1 year
6.3 Hand wringing at 3
months
6.4 Hand wringing at 1 year
6.5 Fine hand co-ordination
at 3 months
6.6 Fine hand co-ordination
at 1 year
6.7 Heavy load bearing at 3
months
6.8 Heavy load bearing at 1
year
No. of
studies
No. of
participants
9
9
521
Risk Ratio (M-H, Fixed, 95% CI)
0.82 [0.71, 0.95]
Subtotals only
9
610
0.64 [0.55, 0.74]
9
610
1.09 [0.95, 1.25]
11
2
612
0.73 [0.55, 0.98]
Totals not selected
1
Not estimable
2
Not estimable
1
Not estimable
2
Not estimable
1
Mean Difference (IV, Fixed, 95% CI)
Totals not selected
1
1
1
2
Not estimable
Not estimable
Not estimable
Totals not selected
1
1
1
Not estimable
Not estimable
Not estimable
1
1
Not estimable
Not estimable
1
Not estimable
1
Not estimable
1
Not estimable
Statistical method
Effect size
46
6.9 Difficulty in turning keys
or taps at 7 years
6.10 Difficulty in picking up
small objects and turning door
handles at 7 years
7 Job change because of injury
7.1 At 6 months
7.2 At 1 year
7.3 At 2 years
8 Mass grip strength (% of normal
side)
8.1 Results at around 1 year
8.2 Results at 7 years follow
up
9 Grip, chuck and pinch strengths
(injured - normal side): units
not given
9.1 Grip strength at 2 years
9.2 Chuck strength at 2 years
9.3 Pinch strength at 2 years
10 Maximal voluntary contraction:
injured - uninjured side
(Newtons)
10.1 Results at 18 weeks
10.2 Results at 2 years
11 Persistent pain (1 year & 7
years)
11.1 At 1 year
11.2 Radiocarpal pain at 1
year
11.3 Ulnocarpal pain at 1 year
11.4 Radioulnar pain at 1 year
11.5 At 7 years
12 Pain (6 months)
12.1 Pain at rest
12.2 Pain on movement
12.3 Ulnar compression pain
13 Range of movement at 1 year
(% of normal side)
13.1 Flexion
13.2 Extension
13.3 Radial deviation
13.4 Ulnar deviation
13.5 Supination
13.6 Pronation
13.7 Flexion/extension
13.8 Overall range of
movement
14 Range of movement at 2 years
(injured - normal side)
14.1 Flexion (degrees)
14.2 Extension (degrees)
1
Not estimable
1
Not estimable
1
1
1
1
4
Mean Difference (IV, Random, 95% CI)
Totals not selected
Not estimable
Not estimable
Not estimable
Totals not selected
4
1
Not estimable
Not estimable
1
Totals not selected
1
1
1
1
Not estimable
Not estimable
Not estimable
Totals not selected
1
1
2
Not estimable
Not estimable
Totals not selected
1
1
Not estimable
Not estimable
1
1
1
1
1
1
1
3
Not estimable
Not estimable
Not estimable
Totals not selected
Not estimable
Not estimable
Not estimable
Totals not selected
2
2
1
1
1
1
1
1
Not estimable
Not estimable
Not estimable
Not estimable
Not estimable
Not estimable
Not estimable
Not estimable
1
Totals not selected
1
1
Not estimable
Not estimable
47
(degrees)
14.4 Ulnar deviation (degrees)
14.5 Supination (degrees)
14.6 Pronation (degrees)
15 Range of movement at 1 year
(degrees)
16 Range of movement at 7 years
(degrees)
17 Complications
17.1 Redisplacement /
recurrent instability
17.2 Redisplacement resulting
in secondary treatment
17.3 Distal radial ulnar joint
instability
17.4 Plaster cast problems
(swollen thumb; loose plaster)
17.5 Pin track infection
17.6 Pin loosening and other
pin site problems
17.7 Premature frame/fixator
removal
17.8 Osteomyelitis
17.9 Wound infection
17.10 Tendon injury/rupture
17.11 ”Dorsal medial
neuropraxia”
17.12 ”Transient neuropraxia”
17.13 Median nerve
compression /Carpal tunnel
syndrome
17.14 Radial nerve neuritis or
neuropathy
17.15 Superficial radial nerve
paraesthesia or injury
17.16 Ulnar nerve
compression
1
Not estimable
1
1
1
1
1
1
1
Not estimable
Not estimable
Not estimable
Totals not selected
Not estimable
Not estimable
Not estimable
1
1
1
1
1
1
1
Not estimable
Not estimable
Not estimable
Totals not selected
Not estimable
Not estimable
Not estimable
1
1
1
15
5
422
Not estimable
Not estimable
Not estimable
Subtotals only
0.20 [0.13, 0.32]
9
694
0.17 [0.09, 0.32]
1
113
1.64 [0.28, 9.44]
1
32
0.23 [0.01, 4.35]
11
7
846
433
12.02 [5.07, 28.49]
5.07 [1.34, 19.26]
3
313
3.25 [0.39, 27.00]
4
1
5
1
332
90
339
90
2.47 [0.10, 59.70]
Not estimable
0.26 [0.05, 1.52]
1.52 [0.06, 36.34]
1
6
32
508
2.27 [0.23, 22.56]
0.50 [0.21, 1.15]
3
204
2.55 [0.98, 6.68]
4
291
7.71 [1.77, 33.54]
2
203
0.2 [0.01, 3.97]
48
17.17 Reflex sympathetic
dystrophy
17.18 Severe finger stiffness
17.19 Dupuytren contracture
17.20 Arthritis
17.21 Refracture
18 Reflex sympathetic dystrophy exploratory analysis
18.1 Primary treatment
18.2 Redisplaced fractures
19 Cosmetic deformity
19.1 Cosmetic deformity
(undefined)
19.2 Prominent ulnar styloid
19.3 Radial deviation of hand
19.4 Residual dinner fork
deformity
20 Patient dissatisfied with wrist
21 Anatomical grading: not
excellent
22 Anatomical grading: fair or
poor
23 Anatomical displacement
23.1 Loss in dorsal angulation
(degrees)
23.2 Loss in radial angulation
(degrees)
23.3 Loss in radial length
(radial shortening) (mm) at
around 1 year follow up
23.4 Loss in radial length
(radial shortening) (mm) at 7
years follow up
23.5 Loss in dorsal
displacement (mm)
23.6 Loss in radial
displacement (mm)
24 Anatomical measurements
24.1 Dorsal angulation
(degrees) at 13 weeks to 13
months follow up
24.2 Dorsal angulation
(degrees) at 7 years follow up
24.3 Radial angulation
(degrees)
24.4 Ulnar variance (mm)
25 Structural deformity
25.1 Malunion (as defined by
trialist)
25.2 Malunion at 7 years
follow up
11
731
1.31 [0.74, 2.32]
1
1
2
1
11
61
32
121
35
0.13 [0.01, 2.32]
5.63 [0.29, 108.63]
0.73 [0.40, 1.34]
2.84 [0.12, 65.34]
Subtotals only
9
2
2
1
598
133
1.03 [0.53, 1.98]
2.67 [0.75, 9.47]
Totals not selected
Not estimable
Not estimable
Not estimable
Not estimable
1
1
1
1
5
371
Totals not selected
0.53 [0.45, 0.61]
6
400
0.17 [0.11, 0.27]
5
0
Totals not selected
Not estimable
1
Not estimable
4
Not estimable
1
Not estimable
1
Not estimable
1
Not estimable
6
6
Totals not selected
Not estimable
1
Not estimable
1
Not estimable
1
6
2
198
Not estimable
Subtotals only
0.58 [0.41, 0.81]
1
86
0.96 [0.63, 1.47]
49
25.3 Carpal collapse
25.4 Dorsal tilt increase due
to ”late collapse”
25.5 Volar angulation of distal
fragment
25.6 Step-off >/= 2 mm
(intra-articular alignment)
25.7 Loss in position postimmobilisation
25.8 Non-congruous joint
surface for die-punch fractures
1
1
90
41
0.89 [0.55, 1.45]
0.64 [0.23, 1.79]
1
41
1.28 [0.29, 5.59]
1
32
5.63 [0.29, 108.63]
1
50
0.14 [0.01, 2.63]
1
31
0.48 [0.24, 0.97]
Analysis 1.1. Comparison 1 External fixation versus plaster cast, Outcome 1 Functional grading: not
excellent.
Review:
Comparison: 1 External fixation versus plaster cast
Outcome: 1 Functional grading: not excellent
Study or subgroup
External fixation
Plaster cast
n/N
n/N
9/25
16/25
9.8 %
0.56 [ 0.31, 1.02 ]
10/22
16/24
9.4 %
0.68 [ 0.40, 1.17 ]
Hegeman 2004
8/15
11/17
6.3 %
0.82 [ 0.46, 1.49 ]
Horne 1990
9/16
8/13
5.4 %
0.91 [ 0.50, 1.68 ]
Jenkins 1989
43/68
41/56
27.5 %
0.86 [ 0.68, 1.10 ]
Kapoor 2000
12/18
21/23
11.3 %
0.73 [ 0.51, 1.04 ]
17/35
23/35
14.1 %
0.74 [ 0.49, 1.12 ]
Roumen 1991
14/21
9/22
5.4 %
1.63 [ 0.91, 2.93 ]
Young 2003
12/36
21/50
10.8 %
0.79 [ 0.45, 1.40 ]
256
265
100.0 %
0.82 [ 0.71, 0.95 ]
Howard 1989
Abbaszadegan 1990
Total (95% CI)
Risk Ratio
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
Total events: 134 (External fixation), 166 (Plaster cast)
Heterogeneity: Chi2 = 8.21, df = 8 (P = 0.41); I2 =3%
Test for overall effect: Z = 2.66 (P = 0.0079)
0.1 0.2
0.5
Favours fixation
1
2
5
10
Favours plaster cast
50
Analysis 1.2. Comparison 1 External fixation versus plaster cast, Outcome 2 Functional grading: not
excellent. Worst and best case scenarios sensitivity analyses.
Review:
Outcome: 2 Functional grading: not excellent. Worst and best case scenarios sensitivity analyses
Study or subgroup
External fixation
Plaster cast
n/N
n/N
Risk Ratio
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Sensitivity analysis 1: worst case for plaster cast
Howard 1989
9/25
16/25
7.8 %
0.56 [ 0.31, 1.02 ]
10/23
16/24
7.6 %
0.65 [ 0.38, 1.12 ]
Hegeman 2004
8/15
11/17
5.0 %
0.82 [ 0.46, 1.49 ]
Horne 1990
9/16
8/13
4.3 %
0.91 [ 0.50, 1.68 ]
Jenkins 1989
43/84
54/69
28.9 %
0.65 [ 0.51, 0.83 ]
Kapoor 2000
12/28
31/33
13.9 %
0.46 [ 0.29, 0.71 ]
17/35
23/35
11.2 %
0.74 [ 0.49, 1.12 ]
Roumen 1991
14/21
9/22
4.3 %
1.63 [ 0.91, 2.93 ]
Young 2003
12/59
37/66
17.0 %
0.36 [ 0.21, 0.63 ]
306
304
100.0 %
0.64 [ 0.55, 0.74 ]
9/25
16/25
9.6 %
0.56 [ 0.31, 1.02 ]
11/23
16/24
9.4 %
0.72 [ 0.43, 1.20 ]
Hegeman 2004
8/15
11/17
6.2 %
0.82 [ 0.46, 1.49 ]
Horne 1990
9/16
8/13
5.3 %
0.91 [ 0.50, 1.68 ]
Jenkins 1989
59/84
41/69
27.0 %
1.18 [ 0.93, 1.50 ]
Kapoor 2000
22/28
21/33
11.6 %
1.23 [ 0.89, 1.70 ]
17/35
23/35
13.8 %
0.74 [ 0.49, 1.12 ]
Roumen 1991
14/21
9/22
5.3 %
1.63 [ 0.91, 2.93 ]
Young 2003
35/59
21/66
11.9 %
1.86 [ 1.24, 2.81 ]
306
304
100.0 %
1.09 [ 0.95, 1.25 ]
Abbaszadegan 1990
Subtotal (95% CI)
Test for overall effect: Z = 5.82 (P < 0.00001)
2 Sensitivity analysis 2: best case for plaster cast
Howard 1989
Abbaszadegan 1990
Subtotal (95% CI)
0.1 0.2
0.5
Favours fixation
1
2
5
10
51
Analysis 1.3. Comparison 1 External fixation versus plaster cast, Outcome 3 Functional grading: fair or poor.
Review:
Outcome: 3 Functional grading: fair or poor
Study or subgroup
External fixation
Plaster cast
n/N
n/N
Abbaszadegan 1990
3/22
9/24
10.5 %
0.36 [ 0.11, 1.17 ]
Hegeman 2004
2/15
3/17
3.4 %
0.76 [ 0.15, 3.93 ]
Horne 1990
5/16
3/13
4.0 %
1.35 [ 0.40, 4.63 ]
Howard 1989
6/25
7/25
8.5 %
0.86 [ 0.34, 2.19 ]
Jenkins 1989
18/68
12/56
16.1 %
1.24 [ 0.65, 2.34 ]
Kapoor 2000
4/18
13/23
13.9 %
0.39 [ 0.15, 1.00 ]
7/35
15/35
18.3 %
0.47 [ 0.22, 1.00 ]
Roumen 1991
9/21
3/22
3.6 %
3.14 [ 0.98, 10.04 ]
Stein 1990
4/40
6/22
9.4 %
0.37 [ 0.12, 1.16 ]
Young 2003
2/36
3/50
3.1 %
0.93 [ 0.16, 5.26 ]
Zheng 2003
2/12
9/17
9.1 %
0.31 [ 0.08, 1.20 ]
308
304
100.0 %
0.73 [ 0.55, 0.98 ]
Total (95% CI)
Risk Ratio
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
0.1 0.2
0.5
Favours fixation
1
2
5
10
52
Analysis 1.4. Comparison 1 External fixation versus plaster cast, Outcome 4 Subjective and objective
functional evaluation.
Review:
Outcome: 4 Subjective and objective functional evaluation
Study or subgroup
External fixation
Plaster cast
n/N
n/N
Risk Ratio
Risk Ratio
43/68
41/56
0.86 [ 0.68, 1.10 ]
18/68
12/56
1.24 [ 0.65, 2.34 ]
4/40
6/22
0.37 [ 0.12, 1.16 ]
16/68
18/56
0.73 [ 0.41, 1.30 ]
Jenkins 1989
2/68
2/56
0.82 [ 0.12, 5.66 ]
Stein 1990
4/40
7/22
0.31 [ 0.10, 0.96 ]
M-H,Fixed,95% CI
M-H,Fixed,95% CI
1 Subjective grading: not excellent
Jenkins 1989
2 Subjective grading: fair/poor
Jenkins 1989
Stein 1990
3 Objective grading: not excellent
Jenkins 1989
4 Objective grading: fair/poor
0.01
0.1
Favours fixation
1
10
100
53
Analysis 1.5. Comparison 1 External fixation versus plaster cast, Outcome 5 Upper extremity function part
of Musculoskeletal Function Assessment tool (0 to 100: maximum disability).
Review:
Outcome: 5 Upper extremity function part of Musculoskeletal Function Assessment tool (0 to 100: maximum disability)
Study or subgroup
External fixation
Plaster cast
Mean Difference
Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Fixed,95% CI
IV,Fixed,95% CI
51
15.8 (20)
57
22.4 (25.6)
-6.60 [ -15.22, 2.02 ]
46
8.6 (14.9)
48
12.2 (18.2)
-3.60 [ -10.31, 3.11 ]
44
12.7 (22.9)
41
15.6 (23.9)
-2.90 [ -12.87, 7.07 ]
1 At 6 months
Kreder 2006
2 At 1 year
Kreder 2006
3 At 2 years
Kreder 2006
-100
-50
Favours fixation
0
50
100
54
Analysis 1.6. Comparison 1 External fixation versus plaster cast, Outcome 6 Difficulties in activities of daily
living.
Review:
Outcome: 6 Difficulties in activities of daily living
Study or subgroup
External fixation
Plaster cast
n/N
n/N
Risk Ratio
Risk Ratio
8/15
3/17
3.02 [ 0.98, 9.36 ]
1/15
2/17
0.57 [ 0.06, 5.64 ]
13/15
11/17
1.34 [ 0.89, 2.00 ]
8/15
3/17
3.02 [ 0.98, 9.36 ]
10/15
3/17
3.78 [ 1.27, 11.21 ]
2/15
5/17
0.45 [ 0.10, 2.00 ]
12/15
13/17
1.05 [ 0.73, 1.51 ]
9/15
10/17
1.02 [ 0.57, 1.81 ]
4/36
4/50
1.39 [ 0.37, 5.19 ]
9/50
0.77 [ 0.28, 2.11 ]
M-H,Fixed,95% CI
M-H,Fixed,95% CI
1 Lifting cup at 3 months
Hegeman 2004
2 Lifting cup at 1 year
Hegeman 2004
3 Hand wringing at 3 months
Hegeman 2004
4 Hand wringing at 1 year
Hegeman 2004
5 Fine hand co-ordination at 3 months
Hegeman 2004
6 Fine hand co-ordination at 1 year
Hegeman 2004
7 Heavy load bearing at 3 months
Hegeman 2004
8 Heavy load bearing at 1 year
Hegeman 2004
9 Difficulty in turning keys or taps at 7 years
Young 2003
10 Difficulty in picking up small objects and turning door handles at 7 years
Young 2003
5/36
0.01
0.1
Favours fixation
1
10
100
55
Analysis 1.7. Comparison 1 External fixation versus plaster cast, Outcome 7 Job change because of injury.
Review:
Outcome: 7 Job change because of injury
Study or subgroup
External fixation
Plaster cast
n/N
n/N
Risk Ratio
Risk Ratio
12/51
11/57
1.22 [ 0.59, 2.52 ]
1/46
4/48
0.26 [ 0.03, 2.25 ]
1/44
2/41
0.47 [ 0.04, 4.95 ]
M-H,Fixed,95% CI
M-H,Fixed,95% CI
1 At 6 months
Kreder 2006
2 At 1 year
Kreder 2006
3 At 2 years
Kreder 2006
0.01
0.1
1
10
Favours fixation
100
Analysis 1.8. Comparison 1 External fixation versus plaster cast, Outcome 8 Mass grip strength (% of
normal side).
Review:
Outcome: 8 Mass grip strength (% of normal side)
Study or subgroup
External fixation
Plaster cast
Mean Difference
Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Random,95% CI
IV,Random,95% CI
Hegeman 2004
15
71 (32)
17
78 (19)
-7.00 [ -25.54, 11.54 ]
Jenkins 1989
68
93.88 (9.4)
56
86.65 (19.6)
7.23 [ 1.63, 12.83 ]
McQueen 1996
54
59.19 (29.51)
28
68 (28)
-8.81 [ -21.83, 4.21 ]
Young 2003
48
86 (14)
60
73 (9)
13.00 [ 8.43, 17.57 ]
36
96 (30)
50
99 (30)
-3.00 [ -15.85, 9.85 ]
1 Results at around 1 year
2 Results at 7 years follow up
Young 2003
-100
-50
0
50
100
Favours fixation
56
Analysis 1.9. Comparison 1 External fixation versus plaster cast, Outcome 9 Grip, chuck and pinch
strengths (injured - normal side): units not given.
Review:
Outcome: 9 Grip, chuck and pinch strengths (injured - normal side): units not given
Study or subgroup
External fixation
Plaster cast
Mean Difference
Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Random,95% CI
IV,Random,95% CI
44
-1.5 (8.7)
41
-4.7 (7)
3.20 [ -0.15, 6.55 ]
44
-0.38 (1.5)
41
0.17 (1.9)
-0.55 [ -1.28, 0.18 ]
44
0.4 (2.5)
41
0.23 (1.8)
0.17 [ -0.75, 1.09 ]
1 Grip strength at 2 years
Kreder 2006
2 Chuck strength at 2 years
Kreder 2006
3 Pinch strength at 2 years
Kreder 2006
-10
-5
0
5
10
Favours fixation
Analysis 1.10. Comparison 1 External fixation versus plaster cast, Outcome 10 Maximal voluntary
contraction: injured - uninjured side (Newtons).
Review:
Outcome: 10 Maximal voluntary contraction: injured - uninjured side (Newtons)
Study or subgroup
External fixation
Plaster cast
Mean Difference
Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Random,95% CI
IV,Random,95% CI
11
86.9 (50.1)
15
84.67 (48.33)
2.23 [ -36.17, 40.63 ]
11
21.3 (48.9)
15
24.93 (42.95)
-3.63 [ -39.79, 32.53 ]
1 Results at 18 weeks
Lagerstrom 1999
2 Results at 2 years
Lagerstrom 1999
-100
-50
0
50
100
Favours fixation
57
Analysis 1.11. Comparison 1 External fixation versus plaster cast, Outcome 11 Persistent pain (1 year & 7
years).
Review:
Outcome: 11 Persistent pain (1 year % 7 years)
Study or subgroup
External fixation
Plaster cast
n/N
n/N
Risk Ratio
Risk Ratio
5/48
4/60
1.56 [ 0.44, 5.50 ]
2/15
3/17
0.76 [ 0.15, 3.93 ]
2/15
3/17
0.76 [ 0.15, 3.93 ]
2/15
3/17
0.76 [ 0.15, 3.93 ]
6/36
11/50
0.76 [ 0.31, 1.86 ]
M-H,Fixed,95% CI
M-H,Fixed,95% CI
1 At 1 year
Young 2003
2 Radiocarpal pain at 1 year
Hegeman 2004
3 Ulnocarpal pain at 1 year
Hegeman 2004
4 Radioulnar pain at 1 year
Hegeman 2004
5 At 7 years
Young 2003
0.01
0.1
1
Favours fixation
10
100
Analysis 1.12. Comparison 1 External fixation versus plaster cast, Outcome 12 Pain (6 months).
Review:
Outcome: 12 Pain (6 months)
Study or subgroup
External fixation
Plaster cast
n/N
n/N
Risk Ratio
Risk Ratio
1/21
0/22
3.14 [ 0.13, 72.96 ]
2/21
4/22
0.52 [ 0.11, 2.56 ]
6/21
3/22
2.10 [ 0.60, 7.32 ]
M-H,Fixed,95% CI
M-H,Fixed,95% CI
1 Pain at rest
Roumen 1991
2 Pain on movement
Roumen 1991
3 Ulnar compression pain
Roumen 1991
0.01
0.1
Favours fixation
1
10
100
58
Analysis 1.13. Comparison 1 External fixation versus plaster cast, Outcome 13 Range of movement at 1
year (% of normal side).
Review:
Outcome: 13 Range of movement at 1 year (% of normal side)
Study or subgroup
External fixation
Plaster cast
Mean Difference
Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Fixed,95% CI
IV,Fixed,95% CI
Hegeman 2004
15
89 (19)
17
89 (17)
0.0 [ -12.56, 12.56 ]
Jenkins 1989
68
87.83 (14.79)
56
89.65 (13.09)
-1.82 [ -6.73, 3.09 ]
Hegeman 2004
15
88 (20)
17
72 (21)
16.00 [ 1.78, 30.22 ]
Jenkins 1989
68
94.29 (12.06)
56
95.54 (11.24)
-1.25 [ -5.36, 2.86 ]
68
92.13 (15.77)
56
95.12 (12.28)
-2.99 [ -7.93, 1.95 ]
68
90.58 (15.33)
56
93.69 (14.57)
-3.11 [ -8.39, 2.17 ]
68
95.88 (9.45)
56
98.77 (7.98)
-2.89 [ -5.96, 0.18 ]
68
97.48 (10.02)
56
96.62 (8.63)
0.86 [ -2.42, 4.14 ]
54
86.56 (11.65)
28
83 (14)
3.56 [ -2.49, 9.61 ]
54
89 (13)
28
93 (11)
-4.00 [ -9.35, 1.35 ]
1 Flexion
2 Extension
3 Radial deviation
Jenkins 1989
4 Ulnar deviation
Jenkins 1989
5 Supination
Jenkins 1989
6 Pronation
Jenkins 1989
7 Flexion/extension
McQueen 1996
8 Overall range of movement
McQueen 1996
-100
-50
0
50
100
Favours fixation
59
years (injured - normal side).
Review:
Outcome: 14 Range of movement at 2 years (injured - normal side)
Study or subgroup
External fixation
Plaster cast
Mean Difference
Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Fixed,95% CI
IV,Fixed,95% CI
44
-8.9 (8.3)
41
-14.5 (15.2)
5.60 [ 0.34, 10.86 ]
44
-4.6 (8.9)
41
-6.2 (7.1)
1.60 [ -1.81, 5.01 ]
44
0 (5.9)
41
-3.5 (8.8)
3.50 [ 0.29, 6.71 ]
44
-3 (6.6)
41
-6 (12.4)
3.00 [ -1.27, 7.27 ]
44
-7.5 (14.2)
41
-1.1 (13.9)
-6.40 [ -12.38, -0.42 ]
44
-4.6 (20.5)
41
-3.9 (7.8)
-0.70 [ -7.21, 5.81 ]
1 Flexion (degrees)
Kreder 2006
2 Extension (degrees)
Kreder 2006
3 Radial deviation (degrees)
Kreder 2006
4 Ulnar deviation (degrees)
Kreder 2006
5 Supination (degrees)
Kreder 2006
6 Pronation (degrees)
Kreder 2006
-100
-50
0
50
100
Favours fixation
60
year.
Review:
Outcome: 15 Range of movement at 1 year
Study or subgroup
External fixation
Plaster cast
Mean Difference
Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Fixed,95% CI
IV,Fixed,95% CI
48
63 (5.3)
60
61 (5.8)
2.00 [ -0.10, 4.10 ]
48
60 (5.7)
60
60 (7.1)
0.0 [ -2.41, 2.41 ]
48
21 (3.1)
60
22 (4.3)
-1.00 [ -2.40, 0.40 ]
48
36 (4)
60
33 (5)
3.00 [ 1.30, 4.70 ]
48
87 (5)
60
86 (4)
1.00 [ -0.74, 2.74 ]
48
90 (0.6)
60
88 (0.2)
2.00 [ 1.82, 2.18 ]
1 Flexion (degrees)
Young 2003
Young 2003
Young 2003
Young 2003
Young 2003
Young 2003
-10
-5
0
5
10
Favours fixation
61
years.
Review:
Outcome: 16 Range of movement at 7 years
Study or subgroup
External fixation
Plaster cast
Mean Difference
Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Fixed,95% CI
IV,Fixed,95% CI
36
60 (13)
50
57 (12)
3.00 [ -2.39, 8.39 ]
36
65 (17)
50
71 (11)
-6.00 [ -12.34, 0.34 ]
36
21 (9)
50
22 (8)
-1.00 [ -4.68, 2.68 ]
36
41 (11)
50
40 (8)
1.00 [ -3.22, 5.22 ]
36
86 (7)
50
87 (8)
-1.00 [ -4.19, 2.19 ]
36
88 (8)
50
87 (11)
1.00 [ -3.02, 5.02 ]
1 Flexion (degrees)
Young 2003
Young 2003
Young 2003
Young 2003
Young 2003
Young 2003
-10
-5
0
5
10
Favours fixation
62
Analysis 1.17. Comparison 1 External fixation versus plaster cast, Outcome 17 Complications.
Review:
Outcome: 17 Complications
Study or subgroup
External fixation
Plaster cast
n/N
n/N
Risk Ratio
14/60
16/30
0.44 [ 0.25, 0.77 ]
Pring 1988
0/36
9/39
0.06 [ 0.00, 0.94 ]
0/35
27/35
0.02 [ 0.00, 0.29 ]
Stein 1990
3/40
16/22
0.10 [ 0.03, 0.32 ]
Young 2003
4/59
5/66
0.89 [ 0.25, 3.18 ]
230
192
0.20 [ 0.13, 0.32 ]
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Redisplacement /recurrent instability
McQueen 1996
Subtotal (95% CI)
2 Redisplacement resulting in secondary treatment
Abbaszadegan 1990
0/23
5/24
0.09 [ 0.01, 1.62 ]
Horne 1990
0/17
0/17
0.0 [ 0.0, 0.0 ]
Howard 1989
3/25
9/25
0.33 [ 0.10, 1.09 ]
Jenkins 1989
0/84
4/69
0.09 [ 0.01, 1.67 ]
Kreder 2006
1/54
5/59
0.22 [ 0.03, 1.81 ]
Lagerstrom 1999
0/18
5/17
0.09 [ 0.01, 1.45 ]
Pring 1988
0/36
9/39
0.06 [ 0.00, 0.94 ]
Stein 1990
0/40
11/22
0.02 [ 0.00, 0.40 ]
Young 2003
3/59
3/66
1.12 [ 0.23, 5.33 ]
356
338
0.17 [ 0.09, 0.32 ]
3/54
2/59
1.64 [ 0.28, 9.44 ]
54
59
1.64 [ 0.28, 9.44 ]
Subtotal (95% CI)
3 Distal radial ulnar joint instability
Kreder 2006
Subtotal (95% CI)
Heterogeneity: not applicable
0.001 0.01 0.1
Favours fixation
1
10 100 1000
(Continued . . . )
63
(. . .
Study or subgroup
External fixation
Plaster cast
n/N
n/N
Risk Ratio
M-H,Fixed,95% CI
Continued)
Risk Ratio
M-H,Fixed,95% CI
4 Plaster cast problems (swollen thumb; loose plaster)
Hegeman 2004
0/15
2/17
0.23 [ 0.01, 4.35 ]
15
17
0.23 [ 0.01, 4.35 ]
Abbaszadegan 1990
3/23
0/24
7.29 [ 0.40, 133.82 ]
Hegeman 2004
2/15
0/17
5.63 [ 0.29, 108.63 ]
Howard 1989
2/25
0/25
5.00 [ 0.25, 99.16 ]
Jenkins 1989
26/84
0/69
43.65 [ 2.71, 703.47 ]
Kapoor 2000
1/28
0/33
3.52 [ 0.15, 83.07 ]
Kreder 2006
6/54
1/59
6.56 [ 0.82, 52.71 ]
McQueen 1996
9/60
0/30
9.66 [ 0.58, 160.50 ]
4/35
0/35
9.00 [ 0.50, 161.13 ]
Roumen 1991
0/21
0/22
0.0 [ 0.0, 0.0 ]
Stein 1990
2/40
0/22
2.80 [ 0.14, 55.95 ]
Young 2003
14/59
0/66
32.38 [ 1.97, 531.25 ]
444
402
12.02 [ 5.07, 28.49 ]
Subtotal (95% CI)
5 Pin track infection
Subtotal (95% CI)
Heterogeneity: Chi2 = 3.88, df = 9 (P = 0.92); I2 =0.0%
6 Pin loosening and other pin site problems
Abbaszadegan 1990
0/23
0/24
0.0 [ 0.0, 0.0 ]
Horne 1990
3/15
0/14
6.56 [ 0.37, 116.70 ]
Jenkins 1989
1/84
0/69
2.47 [ 0.10, 59.70 ]
3/35
0/35
7.00 [ 0.37, 130.69 ]
Roumen 1991
2/21
0/22
5.23 [ 0.27, 102.87 ]
Stein 1990
0/40
0/22
0.0 [ 0.0, 0.0 ]
Zheng 2003
1/12
0/17
4.15 [ 0.18, 94.08 ]
230
203
5.07 [ 1.34, 19.26 ]
0/69
4.12 [ 0.20, 84.36 ]
Subtotal (95% CI)
7 Premature frame/fixator removal
Jenkins 1989
2/84
0.001 0.01 0.1
Favours fixation
1
10 100 1000
(Continued . . . )
64
(. . .
Study or subgroup
External fixation
Plaster cast
Risk Ratio
n/N
n/N
McQueen 1996
2/60
0/30
2.54 [ 0.13, 51.31 ]
0/35
0/35
0.0 [ 0.0, 0.0 ]
179
134
3.25 [ 0.39, 27.00 ]
Subtotal (95% CI)
M-H,Fixed,95% CI
Continued)
Risk Ratio
M-H,Fixed,95% CI
8 Osteomyelitis
Abbaszadegan 1990
0/23
0/24
0.0 [ 0.0, 0.0 ]
Jenkins 1989
1/84
0/69
2.47 [ 0.10, 59.70 ]
0/35
0/35
0.0 [ 0.0, 0.0 ]
Stein 1990
0/40
0/22
0.0 [ 0.0, 0.0 ]
182
150
2.47 [ 0.10, 59.70 ]
0/60
0/30
0.0 [ 0.0, 0.0 ]
60
30
0.0 [ 0.0, 0.0 ]
Howard 1989
0/25
1/25
0.33 [ 0.01, 7.81 ]
McQueen 1996
0/60
0/30
0.0 [ 0.0, 0.0 ]
0/35
0/35
0.0 [ 0.0, 0.0 ]
Roumen 1991
0/21
2/22
0.21 [ 0.01, 4.11 ]
Young 2003
0/36
2/50
0.28 [ 0.01, 5.57 ]
177
162
0.26 [ 0.05, 1.52 ]
1/60
0/30
1.52 [ 0.06, 36.34 ]
60
30
1.52 [ 0.06, 36.34 ]
Subtotal (95% CI)
9 Wound infection
McQueen 1996
Subtotal (95% CI)
10 Tendon injury/rupture
Subtotal (95% CI)
11 ”Dorsal medial neuropraxia”
McQueen 1996
Subtotal (95% CI)
12 ”Transient neuropraxia”
0.001 0.01 0.1
Favours fixation
1
10 100 1000
(Continued . . . )
65
(. . .
Study or subgroup
External fixation
Hegeman 2004
Subtotal (95% CI)
Plaster cast
Risk Ratio
M-H,Fixed,95% CI
Continued)
Risk Ratio
n/N
n/N
2/15
1/17
2.27 [ 0.23, 22.56 ]
M-H,Fixed,95% CI
15
17
2.27 [ 0.23, 22.56 ]
13 Median nerve compression /Carpal tunnel syndrome
Howard 1989
0/25
4/25
0.11 [ 0.01, 1.96 ]
Jenkins 1989
0/84
0/69
0.0 [ 0.0, 0.0 ]
Kapoor 2000
0/28
1/33
0.39 [ 0.02, 9.23 ]
McQueen 1996
3/60
1/30
1.50 [ 0.16, 13.82 ]
Young 2003
4/59
6/66
0.75 [ 0.22, 2.51 ]
Zheng 2003
0/12
3/17
0.20 [ 0.01, 3.51 ]
268
240
0.50 [ 0.21, 1.15 ]
Subtotal (95% CI)
14 Radial nerve neuritis or neuropathy
Horne 1990
4/15
0/14
8.44 [ 0.50, 143.77 ]
Howard 1989
1/25
3/25
0.33 [ 0.04, 2.99 ]
Young 2003
8/59
2/66
4.47 [ 0.99, 20.24 ]
99
105
2.55 [ 0.98, 6.68 ]
1/23
0/24
3.13 [ 0.13, 73.01 ]
11/84
0/69
18.94 [ 1.14, 315.78 ]
Stein 1990
3/40
0/22
3.93 [ 0.21, 72.73 ]
Zheng 2003
1/12
0/17
4.15 [ 0.18, 94.08 ]
159
132
7.71 [ 1.77, 33.54 ]
Subtotal (95% CI)
15 Superficial radial nerve paraesthesia or injury
Abbaszadegan 1990
Jenkins 1989
Subtotal (95% CI)
16 Ulnar nerve compression
Howard 1989
0/25
2/25
0.20 [ 0.01, 3.97 ]
Jenkins 1989
0/84
0/69
0.0 [ 0.0, 0.0 ]
0.001 0.01 0.1
Favours fixation
1
10 100 1000
(Continued . . . )
66
(. . .
Study or subgroup
Plaster cast
n/N
n/N
109
94
0.20 [ 0.01, 3.97 ]
Subtotal (95% CI)
Risk Ratio
Continued)
Risk Ratio
External fixation
M-H,Fixed,95% CI
M-H,Fixed,95% CI
17 Reflex sympathetic dystrophy
Hegeman 2004
4/15
1/17
4.53 [ 0.57, 36.23 ]
Horne 1990
0/15
0/14
0.0 [ 0.0, 0.0 ]
Howard 1989
0/25
0/25
0.0 [ 0.0, 0.0 ]
Jenkins 1989
0/32
2/24
0.15 [ 0.01, 3.02 ]
Kapoor 2000
1/28
0/33
3.52 [ 0.15, 83.07 ]
Kreder 2006
1/54
2/59
0.55 [ 0.05, 5.86 ]
McQueen 1996
7/60
1/30
3.50 [ 0.45, 27.16 ]
0/35
2/35
0.20 [ 0.01, 4.02 ]
Roumen 1991
4/21
2/22
2.10 [ 0.43, 10.26 ]
Stein 1990
1/40
0/22
1.68 [ 0.07, 39.65 ]
Young 2003
7/59
7/66
1.12 [ 0.42, 3.00 ]
384
347
1.31 [ 0.74, 2.32 ]
0/28
4/33
0.13 [ 0.01, 2.32 ]
28
33
0.13 [ 0.01, 2.32 ]
2/15
0/17
5.63 [ 0.29, 108.63 ]
15
17
5.63 [ 0.29, 108.63 ]
Howard 1989
8/19
11/16
0.61 [ 0.33, 1.14 ]
Young 2003
1/36
0/50
4.14 [ 0.17, 98.69 ]
55
66
0.73 [ 0.40, 1.34 ]
Subtotal (95% CI)
18 Severe finger stiffness
Kapoor 2000
Subtotal (95% CI)
19 Dupuytren contracture
Hegeman 2004
Subtotal (95% CI)
20 Arthritis
Subtotal (95% CI)
0.001 0.01 0.1
Favours fixation
1
10 100 1000
(Continued . . . )
67
(. . .
Study or subgroup
External fixation
Plaster cast
n/N
n/N
Risk Ratio
M-H,Fixed,95% CI
Continued)
Risk Ratio
M-H,Fixed,95% CI
21 Refracture
Lagerstrom 1999
1/18
0/17
2.84 [ 0.12, 65.34 ]
18
17
2.84 [ 0.12, 65.34 ]
Subtotal (95% CI)
0.001 0.01 0.1
Favours fixation
1
10 100 1000
Analysis 1.18. Comparison 1 External fixation versus plaster cast, Outcome 18 Reflex sympathetic
dystrophy - exploratory analysis.
Review:
Outcome: 18 Reflex sympathetic dystrophy - exploratory analysis
Study or subgroup
External fixation
Plaster cast
n/N
n/N
Risk Ratio
Risk Ratio
Hegeman 2004
4/15
1/17
4.53 [ 0.57, 36.23 ]
Horne 1990
0/15
0/14
0.0 [ 0.0, 0.0 ]
Howard 1989
0/25
0/25
0.0 [ 0.0, 0.0 ]
Jenkins 1989
0/32
2/24
0.15 [ 0.01, 3.02 ]
Kapoor 2000
1/28
0/33
3.52 [ 0.15, 83.07 ]
Kreder 2006
1/54
2/59
0.55 [ 0.05, 5.86 ]
0/35
2/35
0.20 [ 0.01, 4.02 ]
Stein 1990
1/40
0/22
1.68 [ 0.07, 39.65 ]
Young 2003
7/59
7/66
1.12 [ 0.42, 3.00 ]
303
295
1.03 [ 0.53, 1.98 ]
M-H,Fixed,95% CI
M-H,Fixed,95% CI
1 Primary treatment
Subtotal (95% CI)
0.01
0.1
Favours fixation
1
10
100
(Continued . . . )
68
(. . .
Study or subgroup
Risk Ratio
Continued)
Risk Ratio
External fixation
Plaster cast
n/N
n/N
McQueen 1996
7/60
1/30
3.50 [ 0.45, 27.16 ]
Roumen 1991
4/21
2/22
2.10 [ 0.43, 10.26 ]
81
52
2.67 [ 0.75, 9.47 ]
M-H,Fixed,95% CI
M-H,Fixed,95% CI
2 Redisplaced fractures
Subtotal (95% CI)
0.01
0.1
1
Favours fixation
10
100
Analysis 1.19. Comparison 1 External fixation versus plaster cast, Outcome 19 Cosmetic deformity.
Review:
Outcome: 19 Cosmetic deformity
Study or subgroup
External fixation
Plaster cast
n/N
n/N
Risk Ratio
2/18
0/23
6.32 [ 0.32, 123.86 ]
7/15
12/17
0.66 [ 0.35, 1.23 ]
2/15
3/17
0.76 [ 0.15, 3.93 ]
0/15
1/17
0.38 [ 0.02, 8.57 ]
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Cosmetic deformity (undefined)
Kapoor 2000
2 Prominent ulnar styloid
Hegeman 2004
3 Radial deviation of hand
Hegeman 2004
4 Residual dinner fork deformity
Hegeman 2004
0.001 0.01 0.1
Favours fixation
1
10 100 1000
69
Analysis 1.20. Comparison 1 External fixation versus plaster cast, Outcome 20 Patient dissatisfied with
wrist.
Review:
Outcome: 20 Patient dissatisfied with wrist
Study or subgroup
External fixation
Plaster cast
n/N
n/N
2/36
4/50
Young 2003
Risk Ratio
Risk Ratio
M-H,Fixed,95% CI
M-H,Fixed,95% CI
0.69 [ 0.13, 3.59 ]
0.1 0.2
0.5
1
Favours fixation
2
5
10
Analysis 1.21. Comparison 1 External fixation versus plaster cast, Outcome 21 Anatomical grading: not
excellent.
Review:
Outcome: 21 Anatomical grading: not excellent
Study or subgroup
External fixation
Plaster cast
n/N
n/N
Howard 1989
11/25
23/25
14.3 %
0.48 [ 0.30, 0.76 ]
Jenkins 1989
42/81
62/65
42.9 %
0.54 [ 0.44, 0.68 ]
16/35
22/35
13.7 %
0.73 [ 0.47, 1.13 ]
Roumen 1991
14/21
22/22
13.7 %
0.67 [ 0.50, 0.92 ]
7/40
19/22
15.3 %
0.20 [ 0.10, 0.41 ]
202
169
100.0 %
0.53 [ 0.45, 0.61 ]
Stein 1990
Total (95% CI)
Risk Ratio
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
0.1 0.2
0.5
Favours fixation
1
2
5
10
70
Analysis 1.22. Comparison 1 External fixation versus plaster cast, Outcome 22 Anatomical grading: fair or
poor.
Review:
Outcome: 22 Anatomical grading: fair or poor
Study or subgroup
External fixation
Plaster cast
n/N
n/N
Howard 1989
2/25
6/25
5.9 %
0.33 [ 0.07, 1.50 ]
Jenkins 1989
5/81
36/65
39.2 %
0.11 [ 0.05, 0.27 ]
4/35
16/35
15.7 %
0.25 [ 0.09, 0.67 ]
Roumen 1991
5/21
22/22
21.6 %
0.26 [ 0.12, 0.53 ]
Stein 1990
0/40
9/22
11.9 %
0.03 [ 0.00, 0.48 ]
Zheng 2003
1/12
7/17
5.7 %
0.20 [ 0.03, 1.44 ]
214
186
100.0 %
0.17 [ 0.11, 0.27 ]
Total (95% CI)
Risk Ratio
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
0.01
0.1
Favours fixation
1
10
100
71
Analysis 1.23. Comparison 1 External fixation versus plaster cast, Outcome 23 Anatomical displacement.
Review:
Outcome: 23 Anatomical displacement
Study or subgroup
External fixation
Plaster cast
Mean Difference
Mean Difference
N
Mean(SD)
N
Mean(SD)
IV,Random,95% CI
IV,Random,95% CI
81
2.4 (5.04)
65
6.97 (7.49)
-4.57 [ -6.70, -2.44 ]
1 Loss in dorsal angulation (degrees)
2 Loss in radial angulation (degrees)
Jenkins 1989
3 Loss in radial length (radial shortening) (mm) at around 1 year follow up
Jenkins 1989
81
0.73 (2.67)
65
4 (4.28)
-3.27 [ -4.46, -2.08 ]
McQueen 1996
54
2.52 (2.57)
28
2 (3)
0.52 [ -0.79, 1.83 ]
Young 2003
48
0.9 (0.5)
60
1.6 (1)
-0.70 [ -0.99, -0.41 ]
Zheng 2003
12
1.01 (0.76)
17
5.11 (1.96)
-4.10 [ -5.13, -3.07 ]
4 Loss in radial length (radial shortening) (mm) at 7 years follow up
Young 2003
36
1.5 (2)
50
2 (2)
-0.50 [ -1.36, 0.36 ]
15
3.13 (2.1)
14
2.29 (2.81)
0.84 [ -0.98, 2.66 ]
15
1.67 (2.19)
14
2.64 (2.5)
-0.97 [ -2.69, 0.75 ]
5 Loss in dorsal displacement (mm)
Horne 1990
6 Loss in radial displacement (mm)
Horne 1990
-10
-5
Favours fixation
0
5
10
72
Analysis 1.24. Comparison 1 External fixation versus plaster cast, Outcome 24 Anatomical measurements.
Review:
Outcome: 24 Anatomical measurements
Study or subgroup
External fixation
Plaster cast
N
Mean(SD)
Mean Difference
N
Mean(SD)
Mean Difference
IV,Fixed,95% CI
IV,Fixed,95% CI
1 Dorsal angulation (degrees) at 13 weeks to 13 months follow up
Hegeman 2004
15
2.9 (11)
17
12.7 (14.6)
-9.80 [ -18.70, -0.90 ]
Howard 1989
25
11.5 (8.7)
25
17.3 (10.6)
-5.80 [ -11.18, -0.42 ]
Jenkins 1989
81
-6.73 (9.35)
65
7.87 (12.49)
-14.60 [ -18.26, -10.94 ]
McQueen 1996
54
6.44 (12.65)
28
13 (11)
-6.56 [ -11.85, -1.27 ]
Young 2003
48
-0.7 (2.5)
60
3.9 (3.5)
-4.60 [ -5.73, -3.47 ]
Zheng 2003
12
1 (8.8)
17
10.12 (11.1)
-9.12 [ -16.37, -1.87 ]
36
4 (9)
50
3 (10)
1.00 [ -3.04, 5.04 ]
15
22.7 (4.9)
17
17.5 (7.8)
5.20 [ 0.74, 9.66 ]
15
3.3 (5.3)
17
2.2 (2.6)
1.10 [ -1.85, 4.05 ]
2 Dorsal angulation (degrees) at 7 years follow up
Young 2003
3 Radial angulation (degrees)
Hegeman 2004
4 Ulnar variance (mm)
Hegeman 2004
-100
-50
Not applicable
0
50
100
Not applicable
73
Analysis 1.25. Comparison 1 External fixation versus plaster cast, Outcome 25 Structural deformity.
Review:
Outcome: 25 Structural deformity
Study or subgroup
External fixation
Plaster cast
n/N
n/N
Risk Ratio
Weight
McQueen 1996
24/60
20/30
52.6 %
0.60 [ 0.40, 0.90 ]
Young 2003
12/48
27/60
47.4 %
0.56 [ 0.32, 0.98 ]
108
90
100.0 %
0.58 [ 0.41, 0.81 ]
18/36
26/50
100.0 %
0.96 [ 0.63, 1.47 ]
36
50
100.0 %
0.96 [ 0.63, 1.47 ]
25/60
14/30
100.0 %
0.89 [ 0.55, 1.45 ]
60
30
100.0 %
0.89 [ 0.55, 1.45 ]
4/18
8/23
100.0 %
0.64 [ 0.23, 1.79 ]
18
23
100.0 %
0.64 [ 0.23, 1.79 ]
3/18
3/23
100.0 %
1.28 [ 0.29, 5.59 ]
18
23
100.0 %
1.28 [ 0.29, 5.59 ]
0/17
100.0 %
5.63 [ 0.29, 108.63 ]
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Malunion (as defined by trialist)
Subtotal (95% CI)
2 Malunion at 7 years follow up
Young 2003
Subtotal (95% CI)
3 Carpal collapse
McQueen 1996
Subtotal (95% CI)
4 Dorsal tilt increase due to ”late collapse”
Kapoor 2000
Subtotal (95% CI)
5 Volar angulation of distal fragment
Kapoor 2000
Subtotal (95% CI)
6 Step-off >/= 2 mm (intra-articular alignment)
Hegeman 2004
2/15
0.001 0.01 0.1
Favours fixation
1
10 100 1000
(Continued . . . )
74
(. . .
Study or subgroup
Plaster cast
n/N
n/N
15
17
100.0 %
5.63 [ 0.29, 108.63 ]
0/25
3/25
100.0 %
0.14 [ 0.01, 2.63 ]
25
25
100.0 %
0.14 [ 0.01, 2.63 ]
7/20
8/11
100.0 %
0.48 [ 0.24, 0.97 ]
20
11
100.0 %
0.48 [ 0.24, 0.97 ]
Subtotal (95% CI)
Risk Ratio
Weight
Continued)
Risk Ratio
External fixation
M-H,Fixed,95% CI
M-H,Fixed,95% CI
7 Loss in position post-immobilisation
Howard 1989
Subtotal (95% CI)
8 Non-congruous joint surface for die-punch fractures
Jenkins 1989
Subtotal (95% CI)
0.001 0.01 0.1
1
Favours fixation
10 100 1000
APPENDICES
Appendix 1. Search strategy The Cochrane Library (Wiley InterScience)
#1 MeSH descriptor Radius Fractures explode all trees in MeSH products
#2 MeSH descriptor Wrist Injuries explode all trees in MeSH products
#3 (#1 OR #2)
#4 ((distal near radius) or (distal near radial)) in Title, Abstract or Keywords in all products
#5 (colles or smith or smiths) in Title, Abstract or Keywords in all products
#6 wrist* in Title, Abstract or Keywords in all products
#7 (#4 OR #5 OR #6)
#8 fractur* in Title, Abstract or Keywords in all products
#9 (#7 AND #8)
#10 (#3 OR #9)
Appendix 2. Search strategy for MEDLINE (OVID-WEB)
1. exp Radius Fractures/
2. Wrist Injuries/
3. (((distal adj3 (radius or radial)) or wrist or colles or smith$2) adj3 fracture$).ti,ab.
4. or/1-3
75
Appendix 3. Search strategies for CINAHL and EMBASE (OVID-WEB)
CINAHL
EMBASE
1. Radius Fractures/
2. Wrist Injuries/
3. or/1-2
4. (((distal adj3 (radius or radial)) or wrist or colles or smith$2)
adj3 fracture$).ti,ab.
5. or/3-4
6. exp Clinical Trials/
7. exp Evaluation Research/
8. exp Comparative Studies/
9. exp Crossover Design/
10. clinical trial.pt.
11. or/6-10
12. ((clinical or controlled or comparative or placebo or prospective or randomi#ed) adj3 (trial or study)).tw.
13. (random$ adj7 (allocat$ or allot$ or assign$ or basis$ or divid$
or order$)).tw.
14. ((singl$ or doubl$ or trebl$ or tripl$) adj7 (blind$ or mask$)
).tw.
15. (cross?over$ or (cross adj1 over$)).tw.
16. ((allocat$ or allot$ or assign$ or divid$) adj3 (condition$ or
experiment$ or intervention$ or treatment$ or therap$ or control$ or group$)).tw.
17. or/12-16
18. or/11,17
19. and/5,18
1. (((distal adj3 (radius or radial)) or wrist or colles$2 or smith$2)
adj3 fracture$).tw.
2. Colles Fracture/ or Radius Fracture/ or Wrist Fracture/ or Wrist
Injury/
3. or/1-2
4. exp Randomized Controlled trial/
5. exp Double Blind Procedure/
6. exp Single Blind Procedure/
7. exp Crossover Procedure/
8. or/4-8
9. ((clinical or controlled or comparative or placebo or prospective$ or randomi#ed) adj3 (trial or study)).tw.
10. (random$ adj7 (allocat$ or allot$ or assign$ or basis$ or divid$
or order$)).tw.
11. ((singl$ or doubl$ or trebl$ or tripl$) adj7 (blind$ or mask$)
).tw.
12. (cross?over$ or (cross adj1 over$)).tw.
13. ((allocat$ or allot$ or assign$ or divid$) adj3 (condition$ or
experiment$ or intervention$ or treatment$ or therap$ or control$ or group$)).tw.
14. or/9-13
15. or/8,14
16. Animal/ not Human/
17. 15 not 16
18. and/3,17
FEEDBACK
Inclusion of ’pins and plaster’ external fixation
Summary
Comment from Mr David L Shaw (04.12.07):
The authors are to be congratulated on this extensive review of a common problem in current trauma practice. The validity of their
conclusions are let down however by a glaring error in the abstract. The use of “pin and plaster” as a form of external fixation was only
ever routinely applied to unstable tibial fractures or possibly in third world or battlefield situations. The mechanical construct which
one can achieve with wires or screws inserted into the bone and then wrapped in plaster is in no way comparable to the use of a device
specifically designed to stabilise a distal radial fracture.
In relation to the choice between fracture fixation and manipulation, only one of the most relevant questions relates to the risks of
redisplacement and the benefit of remanipulation as opposed to defaulting to operative stabilisation if fracture reduction has been lost
at some time after manipulation has been used as the primary treatment.
Reply
We thank Mr Shaw for his interest in our review and for his feedback.
76
Cochrane reviews are intended for a world-wide audience. It is thus appropriate that lower-cost methods such as ’pins and plaster’ are
considered. Although its results were consistent with the review conclusions, the actual contribution of quantitative evidence from the
only trial testing pins and plaster external fixation to the review and the conclusions was minimal. Mr Shaw may be interested to read
our review on “Different methods of external fixation for treating distal radial fractures in adults”, which includes a comparison of
external fixation versus pins and plaster fixation. Our conclusion of “unknown effectiveness” for this comparison reflects the inadequate
evidence from two trials available to address this comparison but it is still notable that the evidence from neither trial condemned the
use of plaster and pins fixation.
We agree there is a distinction between primary and secondary (upon redisplacement) fixation and consider in our review that both
situations represent fracture instability.
Contributors
Comment from Mr David L Shaw (04.12.07)
Response from HHG Handoll and WJ Gillespie (18.12.07)
WHAT’S NEW
Last assessed as up-to-date: 16 May 2007.
9 May 2008
Amended
Converted to new review format.
HISTORY
Protocol first published: Issue 4, 2006
Review first published: Issue 3, 2007
CONTRIBUTIONS OF AUTHORS
This review was initiated by Helen Handoll (HH) who prepared the first draft of the protocol. This was critically reviewed by the
other two authors, Rajan Madhok (RM) and Jim Huntley (JH). HH searched for trials and contacted trial authors. All three authors
performed study selection. HH and JH reviewed those trials that had not been included in a previous review covering all surgical
interventions. HH repeated her review of the other included trials that had been quality assessed previously by RM and HH. HH
completed the first draft of the review in RevMan. All versions were scrutinised by the other two authors. Helen Handoll is the guarantor
of the review.
77
DECLARATIONS OF INTEREST
None known.
SOURCES OF SUPPORT
Internal sources
• University of Teesside, Middlesbrough, UK.
External sources
• No sources of support supplied
NOTES
Some of the wording in each of several sections of this review (in particular: Synopsis, Background, Methods, Discussion and Implications) is taken either entirely or in only a slightly modified form from a related review on Percutaneous pinning for distal radial fractures
in adults. This has been done to make the review self-contained and to ensure consistency between related reviews without requiring
unnecessary cross-referring by readers.
INDEX TERMS
Medical Subject Headings (MeSH)
∗ Casts, Surgical; Bone Nails; Colles’ Fracture [surgery]; Fracture Fixation [∗ methods]; Radius Fractures [∗ surgery; therapy]; Randomized
Controlled Trials as Topic; Wrist Injuries [surgery; therapy]
MeSH check words
Adult; Aged; Female; Humans; Male; Middle Aged
78

External fixation versus conservative treatment for distal

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