The Furlong® Hemiarthroplasty System

Transcription

The Furlong® Hemiarthroplasty System
D
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He ecifi gne
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art cally
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The Furlong®
Hemiarthroplasty System
Contents
System Benefits
2
Company Overview
2
Furlong® Cemented Hemiarthroplasty
Design Attributes
3
Clinical Evidence
3
Implant Range
5
Operative Technique
7
Instrumentation
10
Furlong® Hydroxyapatite Ceramic Coated Hemiarthroplasty
Design Attributes
13
Clinical Evidence
13
Implant Range
15
Operative Technique
17
Instrumentation
21
System Benefits
The Furlong® Arthroplasty System
• Cemented or H-A.C. Coated stem options and bi-polar or physiological head options
provide clinical flexibility to match surgeon preference
• The fully modular system allows the surgeon to select the implants which best meet the
patients clinical needs
• Versatility of the system allows for easy conversion to a total hip construct should this be
required intra or post operatively
• Easy to use effective instrumentation designed to enhance clinical outcome
• Clinically proven1,2,3
Company Overview
• JRI Limited, established in 1970 by Mr Ronald Furlong FRCS
• Developers of the world’s first H-A.C. coated hip replacement Prosthesis
– first Furlong H-A.C. total hip replacement implanted 9 September 1985
• Market leading peer reviewed clinical results
• Dedicated orthopaedic research, development and manufacturing
2
Furlong® Cemented Hemiarthroplasty
Design Attributes
The Furlong® cemented hemiarthroplasty stem is a Müller type femoral stem that
has been devised to incorporate the design features and clinical success of the
Furlong cemented primary modular stem which has received an ODEP rating
of 10 C
Available in 5 stem sizes, designed to ensure optimal match to patient’s anatomy
Cost effective system compared to a total hip replacement
Collarless, double tapered, polished high nitrogen stainless steel stem,
designed to facilitate accurate placement of the prosthesis in the cement mantle.
Clinical Evidence
72 Implants had been inserted into 71 different patients by 35 different
Surgeons of all grades. No dislocations in any of the 72 patients who had
bi-polar hips inserted during the study period1
Comparable with results of total hip replacement (THR) but without the risk
of dislocation1
Results are significantly better than would be expected with conventional
Hemiarthroplasty in this group of patients1
Eleven of the sixteen able to walk 1 mile before fracture were able to do so
at review. Mean follow up 32 months.1
3
A more flexible choice for you...
...a better outcome for Mary
4
Furlong® Cemented Hemiarthroplasty
The JRI Bipolar head is pre assembled and
available in 1mm increments. It has been
designed specifically to minimize the risk of
the prosthesis assuming a varus position.
The JRI Physiological Head is manufactured
from proven High Nitrogen Stainless Steel. This
increases biocompatibility and provides greater
fatigue strength and corrosion resistance over
conventional medical grade stainless steel.
12-14 Taper allows for easy
conversion to a total hip at a later
date should this be required
The highly polished surface
finish allows for controlled
subsidence and self locking in
the cement mantle.
Based on the proven 1979
design of the Furlong® Straight
Stem. The high nitrogen stainless
steel stem is double tapered,
collarless and polished for
longevity of cement fixation.
Longer stem available to cater
for most surgical requirements.
127º
The 127º neck angle increases
stability and reduces the risk of
dislocation.
5
DESCRIPTION
Femoral Stems (Standard Stem)
Extra Extra Small Stem
Extra Small Stem
Small Stem
Medium Stem
Large Stem
Femoral Stems (Long Stem)
Small Stem
Medium Stem
Large Stem
Bipolar Heads
40mm O/D
41mm O/D
42mm O/D
43mm O/D
44mm O/D
45mm O/D
46mm O/D
47mm O/D
48mm O/D
49mm O/D
50mm O/D
51mm O/D
52mm O/D
53mm O/D
54mm O/D
56mm O/D
58mm O/D
Physiological Heads
39mm O/D
40mm O/D
41mm O/D
42mm O/D
43mm O/D
44mm O/D
45mm O/D
46mm O/D
47mm O/D
48mm O/D
49mm O/D
50mm O/D
51mm O/D
52mm O/D
53mm O/D
54mm O/D
56mm O/D
58mm O/D
PRODUCT NO.
95.08.00
95.10.00
95.12.00
95.15.00
95.18.00
95.12.25
95.15.25
95.18.25
94.40.01
94.41.01
94.42.01
94.43.01
94.44.01
94.45.01
94.46.01
94.47.01
94.48.01
94.49.01
94.50.01
94.51.01
94.52.01
94.53.01
94.54.01
94.56.01
94.58.01
93.39.01
93.40.01
93.41.01
93.42.01
93.43.01
93.44.01
93.45.01
93.46.01
93.47.01
93.48.01
93.49.01
93.50.01
93.51.01
93.52.01
93.53.01
93.54.01
93.56.01
93.58.01
6
Furlong® Cemented Hemiarthroplasty
7
1
2
Correct positioning of the patient, on the operating table,
is very important and the hip joint is exposed using a
preferred surgical approach for hemiarthroplasty.
The femoral neck is cut 1-2cm above the lesser trochanter.
(This cut can be determined by where the fracture has
occurred). A trial stem can be used, if required, to help
identify where the neck cut should be and a line made
using a diathermy probe or skin marker.
3
4
The saw cut should be perpendicular to the neck and
the position of the tibia should be vertical while the cut
is made.
The femoral head is removed using the corkscrew. A light
tap may help engagement and purchase into the femoral
head.
5
6
The femoral head size can then be estimated using the
femoral head template guide.
Sizing is confirmed using the trial heads and introducer.
The Labrum is best left intact but, if necessary, can be
sectioned at this point to allow the correct size head to
be selected.
Operative Technique
7
8
The proximal femur is opened using the box chisel which
is positioned laterally and posteriorly so that entry is in line
with the femoral intramedullary canal.
The smallest (4-8mm tapered) intramedullary reamer,
which has a sharp tip, is mounted on the T-Handle, and
used to expose the femoral canal. Care should be taken
with this first reamer and if bone quality is poor then the
8mm intramedullary reamer should be used first, as it has
a more rounded tip. Further straight reamers are used
increasing in 1mm size increments until an acceptable
reaming has been achieved.
9
10
The smallest rasp (extra, extra small) is used to prepare
the proximal femur. The large tommy bar should be
used to control version. If the fit of this first rasp is
unsatisfactory then repeat the procedure increasing rasp
size accordingly. Care should be taken to lateralise the
rasps as they are inserted.
At this point, if required, the appropriate trial stem can be
carefully inserted using the stem impactor.
11
12
The chosen trial head is screwed onto the trial prosthesis
and a reduction attempted. If the reduction is not possible
or is regarded as too tight, remove the trial prosthesis.
The neck should be resected further to permit deeper
seating of the stem. Seat the rasp again and repeat the
trialing process until the reduction is stable.
The trial stem can be removed with the use of the
trial stem extractor. Care must be taken to tap out
of the femur in a neutral position to prevent possible
damage to the femur.
8
Operative Technique Continued
9
13
14
At this point a suitable size of cement restrictor or plug is
chosen, depending on the size of the final intramedullary
reamer used and screwed onto the introducer. The depth
of insertion is determined by placing the cement plug
introducer alongside the trial/prosthesis. The plug is aligned
1–2cm beyond the distal tip of the trial/prosthesis and a
measurement taken from the markings on the introducer
handle. The lateral shoulder of the trial/prosthesis is a
good reference point. (Ref Page 10 Chart A)
The plug is then inserted into the femoral canal at a
depth of 1–2cm beyond the distal tip of the prosthesis.
To remove the introducer handle turn anti-clockwise to
unscrew from the plug. Do not remove the introducer
handle until the plug is seated correctly at the premeasured depth.
15
16
The preferred cementing technique is now used. Modern
techniques recommend the use of a cement plug, lavage,
drying of the femoral canal and retrograde filling with a
cement gun.
Making sure the tibia is vertical, the definitive femoral
stem should be inserted in neutral alignment, to ensure
a continuous circumferential cement mantle, using the
stem impactor and inserted to the depth determined by
the trial prosthesis.
The depth of the stem should be determined by the
height of the centre of rotation of the femoral head on the
contralateral side. If the same size rasp, trial and definitive
stem are used then a cement mantle of approx. 1-2mm
will be obtained. Should a thicker cement mantle be
required, then a smaller size of prosthesis than the size of
the last rasp used, should be selected.
17
18
Before fitting the Bipolar or mono-polar, physiological
femoral head ensure that the cement is fully cured and
set.
The implant head (either bi-polar or mono-polar,
physiological) is fitted onto the stem and impacted using
the femoral head impactor. A light tap is required to
engage the taper.
Operative Technique
19
Finally the joint is reduced, and the wound is closed.
Furlong® Cemented Instrumentation
Chart A
Intramedullary
Rasp
Reamer Size (mm)
Implant Size
Cement Plug (mm)
Extra Extra Small or
10
9
10
Extra Small or
11
Small
12.5
14
Medium or
15
16
Large
17.5 or 20
12
1
DESCRIPTION
1
Cement Plug
2
Size AA
10.0mm Diameter
Size OA
12.5mm Diameter
Size OB
15.0mm Diameter
Size OC
17.5mm Diameter
Size OD
20.0mm Diameter
Cement Plug Introducer
2
PRODUCT NO.
13.00.03
13.00.04
13.00.05
13.00.06
13.00.07
13.00.01
10
Furlong® Cemented Instrumentation
1
4
2
5
3
6
DESCRIPTION
PRODUCT NO.
1
Trial Head Introducer
10.00.44
2
3
4
5
6
Head Impactor
Trial Stem Extractor
Box Chisel
Stem Impactor
Femoral Head Extractor
10.00.47
10.00.08
50.99.45
50.99.34
10.00.21
13
10
7
12
8
11
9
7
8
9
10
11
12
13
11
Intramedullary Reamers
4-8mm
8mm
9mm
14.48.61
14.61.08
14.61.09
10mm
14.61.10
11mm
14.61.11
12mm
14.61.12
13mm
14.61.13
14mm
16mm
Small Tommy Bar
Large Tommy Bar
Hudson Adaptor
Jacobs Adaptor
T Handle
Femoral Head Gauge
14.61.14
14.61.16
10.08.28
10.25.28
10.00.26
10.00.27
10.00.50
64.00.18
15
14
14 Trial Stems (Threaded Spigot)
Extra Extra Small
96.08.08
Extra Small
96.08.10
Small
Medium
Large
Small Trial Long Stem
Medium Trial Long Stem
Large Trial Long Stem
15 Rasps
Extra Extra Small
Extra Small
Small
Medium
Large
96.08.12
96.08.15
96.08.18
96.25.12
96.25.15
96.25.18
50.00.14
50.00.15
50.00.16
50.00.17
50.00.18
16
DESCRIPTION
16
17
PRODUCT NO.
DESCRIPTION
17
Bipolar Trial Heads (Black)
40mm
41mm
42mm
43mm
44mm
45mm
46mm
47mm
48mm
49mm
50mm
51mm
52mm
53mm
54mm
56mm
58mm
Available as a
revision option
64.40.94
64.41.94
64.42.94
64.43.94
64.44.94
64.45.94
64.46.94
64.47.94
64.48.94
64.49.94
64.50.94
64.51.94
64.52.94
64.53.94
64.54.94
64.56.94
64.58.94
PRODUCT NO.
Physiological Trial Heads (White)
39mm
64.39.10
40mm
64.40.10
41mm
64.41.10
42mm
64.42.10
43mm
64.43.10
44mm
64.44.10
45mm
64.45.10
46mm
64.46.10
47mm
64.47.10
48mm
64.48.10
49mm
64.49.10
50mm
64.50.10
51mm
64.51.10
52mm
64.52.10
53mm
64.53.10
54mm
64.54.10
56mm
64.56.10
58mm
64.58.10
12
Furlong® H-A.C. Hemiarthroplasty
Design Attributes
Supravit® H-A.C. coating and stem geometry are identical to the Furlong® H-A.C.
hip replacement, which has an ODEP rating of 10 A
Very impressive clinical results have shown that Supravit makes the
Furlong® H-A.C. Total Hip Replacement, possibly the most successful
uncemented hip stem4-12
Can be used on patients with osteoporotic bone13
Cost effective compared to Total Hip Replacement
Clinical Evidence
We conclude that Hemiarthroplasty with the Hydroxyapatite coated Bipolar Furlong®
prosthesis for displaced intracapsular fracture of the neck of the femur gives good mid term
results in elderly patients for return to mobility, use of mobility aids and freedom from pain2
Modularity of the head allows later conversion to total hip arthroplasty without revision
of the stem2
Use of the Hydroxyapatite–coated stem eliminates the need for cement and its attendant
risks to the cardio respiratory system in the elderly and often frail population2
The results of our study indicate that hip Hemiarthroplasty using the Furlong® H-A.C. coated
implant is associated with good functional recovery in terms of mobility and reliance on
walking aids2
The mean Clinical Rating Score was 70 ( Harris Hip Score 80.6 ). 86% had no pain and 90%
were satisfied. This prosthesis functions well in the active elderly patient with a displaced
intracapsular proximal femoral fracture3
13
A more flexible choice for you...
...a better outcome for Barbara
14
Furlong® H-A.C. Hemiarthroplasty
The JRI Bipolar head is pre assembled and
available in 1mm increments. It has been
designed specifically to minimize the risk of
the prosthesis assuming a varus position.
The JRI Physiological Head is manufactured
from proven High Nitrogen Stainless Steel. This
increases biocompatibility and provides greater
fatigue strength and corrosion resistance over
conventional medical grade stainless steel.
12-14 Taper allows for
an easy conversion to a
total hip replacement at
a later date, should this
be required
127º
The 127º neck angle increases
stability and reduces the risk of
dislocation.
Proximal stem geometry aids
primary fixation of the implant
The collar of the implant
helps neutral alignment of
the prosthesis.
15
Proven stem design of the
Furlong® H-A.C. Total Hip
Replacement
Fully coated with Supravit®
hydroxy-apatite ensuring
even distribution of forces
transmitted through the
prosthesis to the host bone.
DESCRIPTION
PRODUCT NO.
H-A.C. Femoral Stems
9mm
97.09.00
10mm
97.10.00
11mm
97.11.00
12mm
97.12.00
13mm
97.13.00
14mm
97.14.00
16mm
97.16.00
Bipolar Heads
40mm O/D
94.40.01
41mm O/D
94.41.01
42mm O/D
94.42.01
43mm O/D
94.43.01
44mm O/D
94.44.01
45mm O/D
94.45.01
46mm O/D
94.46.01
47mm O/D
94.47.01
48mm O/D
94.48.01
49mm O/D
94.49.01
50mm O/D
94.50.01
51mm O/D
94.51.01
52mm O/D
94.52.01
53mm O/D
94.53.01
54mm O/D
94.54.01
56mm O/D
94.56.01
58mm O/D
94.58.01
Physiological Heads
39mm O/D
93.39.01
40mm O/D
93.40.01
41mm O/D
93.41.01
42mm O/D
93.42.01
43mm O/D
93.43.01
44mm O/D
93.44.01
45mm O/D
93.45.01
46mm O/D
93.46.01
47mm O/D
93.47.01
48mm O/D
93.48.01
49mm O/D
93.49.01
50mm O/D
93.50.01
51mm O/D
93.51.01
52mm O/D
93.52.01
53mm O/D
93.53.01
54mm O/D
93.54.01
56mm O/D
93.56.01
58mm O/D
93.58.01
16
Furlong® H-A.C. Hemiarthroplasty
17
1
2
Correct positioning of the patient, on the operating table,
is very important and the hip joint is exposed using a
preferred surgical approach for hemiarthroplasty.
The femoral neck is resected. (This cut can be determined
by where the fracture has occurred). A trial stem, rasp or
template can be used, if required, to help identify where
the neck cut should be and a line made using a diathermy
probe or skin marker.
3
4
The femoral head is removed using the corkscrew. A light
tap may help engagement and purchase into the femoral
head.
The size of the femoral head can then be estimated
using the femoral head template guide.
5
6
The actual implant head to be used (either bi-polar or
mono-polar, physiological) is determined using the trial
heads and introducer. The Labrum is best left intact but,
if necessary, can be sectioned at this point to allow the
correct size head to be selected.
The proximal femur is opened using the box chisel which
is positioned laterally and posteriorly so that entry is in line
with the femoral intramedullary canal.
Operative Technique
7
8
The smallest (4-8mm tapered) intramedullary reamer,
which has a sharp tip, is mounted on the T-Handle, and
used to open up the femoral canal. Care should be taken
with this first reamer and if the bone quality is poor then
the 8mm intramedullary reamer should be used first in its
place, as it has a more rounded tip.
Next the 9mm intramedullary reamer is used.
9
10
The smallest rasp (Size 9) is used first to prepare the
proximal femur. The small tommy bar is used to control
version.
If the fit of this first rasp is unstable then the next size
of intramedullary reamer is used followed by the
corresponding size of rasp. This ream / rasp technique is
continued until the fit of the rasp is stable.
11
12
With the correct rasp in place remove the rasp handle
and if required, trim the neck using the calcar cutter
fitted onto the T-handle.
With the rasp still in place, the fin cutter is gently tapped
home into the groove in the rasp with the teeth facing the
greater trochanter.
18
Furlong® H-A.C. Hemiarthroplasty
13
At this point, if required, the appropriate trial stem
prosthesis can be carefully inserted using the stem
impactor.
15
The chosen trial head is screwed onto the trial prosthesis
and a reduction attempted. If the reduction is not possible
or is regarded as too tight, the trial prosthesis is removed
and the neck resected further to permit deeper seating
of the stem. The rasp is seated again and the trialing
process repeated until the reduction is satisfactory.
16
The trial stem can be removed with the use of the trial
stem extractor. Care must be taken to tap the trial out
of the femur in a neutral position to prevent possible
damage to the femur.
The definitive femoral stem should be inserted using
the stem impactor and tapped home to the depth
determined by the trial prosthesis.
17
18
Seating of the collar on the calcar is preferred but not
essential.
19
14
The implant head (either bi-polar or mono-polar,
physiological) is fitted onto the stem and impacted using
the nylon femoral head impactor. A light tap is required to
engage the taper.
Operative Technique Continued
19
Finally the joint is reduced and the wound is closed.
20
Furlong® H-A.C. Instrumentation
1
4
2
5
3
6
DESCRIPTION
PRODUCT NO.
1
Trial Head Introducer
10.00.44
2
3
4
5
6
Head Impactor
Trial Stem Extractor
Box Chisel
Stem Impactor
Femoral Head Extractor
10.00.47
10.00.08
50.99.45
50.99.34
10.00.21
13
7
8
11
12
9
10
7
8
9
10
11
12
13
21
Intramedullary Reamers
4-8mm
9mm
14.48.61
14.61.09
10mm
14.61.10
11mm
14.61.11
12mm
14.61.12
13mm
14.61.13
14mm
16mm
Small Tommy Bar
Small Tommy Bar
Fin Cutter
Calcar Cutter
T Handle
Femoral Head Gauge
14.61.14
14.61.16
10.08.28
10.08.28
90.99.02
90.00.23
10.00.50
64.00.18
14
16
15
14 Trial Stems
9mm
98.08.09
10mm
98.08.10
11mm
12mm
13mm
14mm
16mm
15 Rasp Handle
16 Rasps
9mm
10mm
11mm
12mm
13mm
14mm
16mm
98.08.11
98.08.12
98.08.13
98.08.14
98.08.16
200.02.99
91.11.09
91.11.10
91.11.11
91.11.12
91.11.13
91.11.14
91.11.16
17
DESCRIPTION
17
18
PRODUCT NO.
18
Bipolar Trial Heads (Black)
40mm
41mm
42mm
43mm
44mm
45mm
46mm
47mm
48mm
49mm
50mm
51mm
52mm
53mm
54mm
56mm
58mm
DESCRIPTION
64.40.94
64.41.94
64.42.94
64.43.94
64.44.94
64.45.94
64.46.94
64.47.94
64.48.94
64.49.94
64.50.94
64.51.94
64.52.94
64.53.94
64.54.94
64.56.94
64.58.94
PRODUCT NO.
Physiological Trial Heads (White)
39mm
64.39.10
40mm
64.40.10
41mm
64.41.10
42mm
64.42.10
43mm
64.43.10
44mm
64.44.10
45mm
64.45.10
46mm
64.46.10
47mm
64.47.10
48mm
64.48.10
49mm
64.49.10
50mm
64.50.10
51mm
64.51.10
52mm
64.52.10
53mm
64.53.10
54mm
64.54.10
56mm
64.56.10
58mm
64.58.10
22
JRI Services/Education
• Research Funding
• In service support
• Nurse Training
• Consignment stock checks:
• Implants
• Factory Tours
• Instruments
• Furlong Hip Course
• PACS Digital X-Ray templates
References:
1. S Dixon et al. Cemented Bipolar Hemiarthoplasty for Displaced Intracapsular Fracture in the Mobile Active Elderly
Patient. Int. J Care Injured 2004; 35:152-156.
2. P Chandran et al. Mid Term Results of Furlong LOL Uncemented
Hip Hemiarthroplasty for Fractures of the Femoral Neck. Acta Orthop. Belg., 2006; 72:426-433.
3. R Rees et al.
The JRI Bipolar Hemiarthroplasty for the Active Patient With a Displaced Intracapsulat Proximal Femoral Fracture.
BOA 2001. 4. Survivorship of 38 cases in under 50 year olds. N.N. Shah et al J Bone Joint Surg [Br] 2009; 91-B:865-9
5. Survivorship of 331 consecutive cases. J.A.N Shepperd et al J Bone Joint Surg [Br] 2008; 90-B:27-30
6. Survivorship of 134 consecutive cases. A.A. Shetty et al J Bone Joint Surg [Br] 2005; 87-B:1050-4 7. Survivorship in
2212 cases. J.M. Buchanan, Sunderland Royal Hospital Data presented at BOA, Manchester, 26 - 28 September 2007. 8.
Sources: Fisher J, University of Leeds (UK); Pandorf T, CeramTecAG (Germany), 2006 9. Buchanan J.M. A nineteen-year
review of hydroxyapatite ceramic coated hip implants: a clinical and histological evaluation. BOA, 2007; Manchester
26-28th September 2007. 10. Raman R, David D, Eswaramoorthy V, Tiru M, Angus P; Long term results of 586 cementless
primary total hip arthroplasties using H-A.C. coated endoprosthesis: BOA ; Manchester 26-28th September 2007. 11. Escriba
I, Sancho R, Crusi X, Valera M; Hemispherical hydroxyapatite-coated cups for acetabular revision in severe bone defects: 3 to
7 year results. EFORT, Helsinki, Finland, June 4 -10th 2003. 12. Data on file. 13. Data on file – published at EFORT AOS 2008.
Wholly owned by the Furlong Research Charitable Foundation who
independently fund orthopaedic research
Joint Replacement Instrumentation Limited
18 Churchill Way, 35A Business Park, Chapeltown, Sheffield S35 2PY
T: 0114 345 0000 F: 0114 345 0004 W: www.jri-ltd.co.uk
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