Casting - Amazon Web Services

1/4/2014
VuMedi Webinar
Current Concepts in EOS
6 January 2014
Casting
George H.Thompson, MD
Director, Pediatric Orthopaedics
Rainbow Babies and Children’s Hospital
Case Western Reserve University
Cleveland, Ohio, USA
Early Onset Scoliosis:
The Value of Serial
Risser Casts
Thompson GH, Waldren S, Son-Hing JP,
Poe-Kochert C
Rainbow Babies and Children’s Hospital
Case Western Reserve University
Cleveland, Ohio, USA
Serial Risser Casts
Possible “bridge” treatment option in
EOS
• Deformity control in young children
• Delay need for growing rods and
their associated complications
1
1/4/2014
Protocol
RBCH Pediatric Orthopaedic Spine Database
Indications for Risser casting (1999-2010)
• Very young children
2 – 5 years of age
• Progressive deformity
≥ 25° with ≥ 10° documented progression
• Failed orthotic management
Technique
• Cast applied under general
anesthesia (outpatient)
• Pediatric spica cast table
• Traction – head and ankles
• Well molded Risser cast
• Large abdominal window
Post – cast protocol
• Cast change at 3 – 4 month interval
for 2 – 3 years
Risser Cast Application in EOS
2
1/4/2014
Longitudenal traction
Iliac mold
Infantile idiopathic scoliosis - Risser cast
3
1/4/2014
Patients
Pediatric Orthopaedic Spine Database
• 19 patients – serial Risser casts
• 16 females; 3 males
• Diagnoses
Idiopathic infantile / juvenile
9
Syndromic
5
Neuromuscular
5
Congenital
0
Results
Mean age at initial cast 3.7±2.3 years
(range, 1 – 8 years)
Major curve at initial cast 74±18°
(range, 40 – 118 °)
Months in cast 15.8±8.9 months
(range, 4 – 35 months)
Major curve at treatment change 49±27°
(range, 13 – 112°) – 15 patients
Current results
• Still in casts
4
• Growing rods
6
• Orthosis
5
• Lost to follow-up
2
• Fusion
2
Complications
• Skin irritation (minor) 2
• Intolerable
1
4
1/4/2014
27 °
81°
Pre-cast 2+1 yrs 5-08
4+5 yrs 9-10
KL IIS DOB 4-06
Conclusions
Serial Risser casts are an effective intermediate
step in EOS treatment
• Orthotic failure
Delays need for growing rod surgery
May allow return to orthotic management at a
later juvenile age group
Well tolerated by patients and families
Minimal complications
Treatment of EOS:
Casts vs. Growing Rods
Johnston CE, McClung A,
Thompson GH, Poe-Kochert C,
Sanders JO
Growing Spine Study Group
5
1/4/2014
Methods
25 cases from 3 casting centers Dallas, Cleveland, Rochester
Minimum 1yr post cast
25 GR cases from GSSG multicenter
database
Matching criteria
• Age (within 6 months)
• Major curve magnitude (within 10o)
• Diagnosis
Outcome Measures
T1-S1 length, major curve, complications -
•
•
pre-treatment to most recent follow-up
Cast group either in non-op rx
(brace/observation) or followed up to surgical
intervention
GR group still under active management or
when final lengthening / abandonment
Results
Age
Curve
T1-S1cm
Cast
5.09
65.5o
27.5cm
GR
5.41
67.5o
26.0cm
p
.58
.65
.19
Diagnosis
IIS/JIS 9
N-M
6
Synd
10
Diagnosis pairs closely matched
Curve magnitude -> surgical !
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1/4/2014
Results – Outcome
Final followup
Duration
Treatment
Cobb
Cast
2.4 yrs
66.1°
30.8cm
3.3cm
GR
4.5 yrs
47.5°
31.6cm
5.6cm
P
.003
.003
.48
.012
Mean # of treatments
Casts
3.9
GR lengthen 5.6
T1-S1
T1-S1
Total complications
Cast
1/25 (4%)
GR
11/25 (44%)
2.1 per pt
p=.0017
Results
9/25 casted patients have
undergone surgery after mean
1.4 yr (0-3.1) additional delay
“Growth” rate cast 4.0 cm/yr*
GR
2.0 cm/yr
* elongation while in cast only
Summary
GR’s achieved
• Better curve correction (32% vs
none)
• No greater T1-S1 length @ f/u)
• Required longer duration of
treatment + 6 lengthenings to
achieve
• 11 /25 (44%) pts. suffered 23
complications
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1/4/2014
Study Weakness
Casting protocol = casts X 1yr (e.g. n=4), then
brace/observation
Shorter treatment period in cast group
generally expected, change to surgery after
delay
Not directly comparable to GR treatment
period, which is often open-ended
Cast “growth” = elongation from correction,
overestimation due to shorter duration of rx
Significance
First known direct comparison of 2
treatments for EOS with patients
matched for age, diagnosis, severity.
At follow–up GR group had smaller
curves BUT….
- spine length (T1-S1) no difference
- duration of rx doubled - 6 surgeries
- 44% vs. 4% complications
THANK YOU
8
1/4/2014
VEPTR for EOS
Michael G. Vitale MD MPH
Ana Lucia Professor of Orthopaedic Surgery
Children’s Hospital Of New York; Columbia University Medical Center
Chief, Pediatric Spine and Scoliosis Service
Co Director, Division of Pediatric Orthopaedic Surgery
“Rib-Based Distraction Constructs for
EOS”
Michael G. Vitale MD MPH
Ana Lucia Professor of Orthopaedic Surgery
Children’s Hospital Of New York; Columbia University Medical Center
Chief, Pediatric Spine and Scoliosis Service
Co Director, Division of Pediatric Orthopaedic Surgery
-DisclosuresMichael G. Vitale, MD MPH
Columbia University Medical Center
Disclosure: I DO have a financial relationship with a commercial interest.
Royalties: Biomet
Consultant: Stryker, CWSDSG, Biomet
Research Support: OREF, CWSDRF, SRS, POSNA
Divisional Support: OREF
Travel Expenses: CWSDSG, FoxPSDSG
Other: CWSDSG - BOD
POSNA BOD
1
1/4/2014
Consider Surgical Stabilization for
Progressive Curves Before They
Get Too Large
Etiology
Highest
Lowest
Priority
Cobb Angle
(Major Curve)
Congenital/Structural
1: <20°
Neuromuscular
2: 20-49°
Syndromic
3: 50-89°
Idiopathic
4: ≥90°
Maximum Total
Kyphosis
Progression
Modifier
(optional)
(-) <20º
P0: <10°/ yr
N: 21-49°
P1:10-19°/ yr
(+): ≥50°
P2: ≥20°/ yr
C-EOS Vitale et al
Lung Function Deteriorates with Curve Magnitude
Thoracic Height Also Important
Volume

Height
- Thoracic spinal growth
 0-5 yrs: 1.5 cm/yr
 5-10 yrs: 0.7 cm/yr
 10-15 yrs: 1.3 cm/yr
% Normal Ht
- Dimeglio
2
1/4/2014
Patients With < 17 cm of T1=T12
Height Have Better Lung Function
Johnston et al, J Bone Joint Surg Am. 2008
Sagittal Plane Deformity Can Result in Secondary
Thoracic Insufficiency Syndrome
Collapsing Neuromuscular Scoliosis/Myelodysplasia
- With Chest deformity and collapse into the abdomen
Cobb is just a proxy for complex
altered respiratory dynamics
3
1/4/2014
Classifying “Non-Fusion” Techniques
Skaggs, Vitale et al
• Distraction Based Systems:
• e.g. Growing Rods and VEPTR
• Guided Growth
•
e.g. Shilla and Luque trolley
• Compression Based Systems
• e.g. Stapling and tethers
Magic is in the concept, not metal
“Mongrel Constructs”
Original indication for VEPTR
• Constricted hemithorax / fused ribs with
evidence of thoracic insufficiency
• Primary thoracogenic scoliosis where there is a
chest wall tether
4
1/4/2014
Patient CP : Jarcho-Levin Syndrome
2013: VEPTR as a growth rod
– Avoid spine = Avoid inadvertent fusion ?
– Safer in young children esp in (kyphoscoliosis)
– Preserve bone stock for later
– “Minimally Invasive” Surgery for Sick / Involved
Kids
– Easier to lengthen / lengthens in kyphotic segment
– Less stiffness at anchor  Less Hardware migration/
Rib Fracture?
Hooks on Ribs:
Do not expose or fuse upper spine
Spine Remain Virgin (no thoracotomy)
Courtesy of David Skaggs, MD
5
1/4/2014
Hooks on Ribs: Lower Profile
Spine
Anchors
Courtesy of David Skaggs, MD
“Attaching” to Ribs Instead of Spine
“Sloppy, Low Modulus Construct”
“Attaching” to Pelvis Instead of Spine
6
1/4/2014
Stiffer Construct Leads to Greater
Risk of Failure
• 11 yo with SMA II
• Instrumented with
VEPTR since age 9
• Repeated
lengthenings w/o
complications
• 3/2012: Revised to
Pelvis to improve
seating
• 1 wk post op, Proximal
Anchor Failure noted
Multicenter Hybrid Study
Skaggs, Vitale, et al.
•
Retrospective study
•
28 patients, 6 institutions
•
Inclusion criteria:
– Children <10 years
– Rib based growth rods
– Minimum 2 year follow-up
• No proximal anchor failure when 4 or more
proximal anchors used in dual rod
constructs
Are Proximal Rib Anchors Protective Against Rod
Breakage in Distraction-Based Growing Rods?
Yamaguchi, Skaggs, Vitale, et al (not published)
• Proximal spine-anchored distraction-based growing
rods have 3.6x increased risk of lifetime rod breakage
than rib-anchored growing rods.
• Fewer Rib-anchored rod breaks may be due to:
– less rigid at the hook-rib interface
– normal motion of the costovertebral joint
7
1/4/2014
Pedicle Screws in the Very Young:
Lessons Learned
• Case report of screw
pullout in growing rod
resulting in paralysis
•Foundation should have
at least 2 screws at
different levels
Spastic paraparesis, urinary retention
5 mo after last uneventful lengthening
9/06
9/08
9/08
2 screws;
2 hooks
VEPTR vs Growth Rod:
Advantages for Lengthening to VEPTR
1x vs 2x lengthening
Can lengthen in T Spine
VEPTR
8
1/4/2014
Patient TO
• 18 month old
girl
• Jehovah’s
Witness
3/2005
• Horizontal
Gaze Palsy
3/2005
Patient TO: Intra-Operative Correction
with Rib/Pedicle Hybrid
1 wk post-op
3/2005
TO: Conversion to VEPTR
9 Lengthenings
3/2005, 18mo old
The beginning
3/2009, 6 yrs old
Getting There
9
1/4/2014
Staged Revision to Spine
-Jehova’s Witness
5/2012 - 9 yo
8/2010
Rib Support to slow parasol in SMA
Patient EW:
VEPTR T2 to Pelvis Hybrid for SMA
T6-L4
84
Pre-operative
T8-L4
46
4/26/12
Restoration of sag plane
prevents 2º insufficiency
Rib Support to slow parasol in SMA
Patient O.K.
•
3 yo boy with SMA type I,
•
Cough Assist nightly; G-tube
•
Coronal curve 23º  54º in 6
months
•
Kyphotic thru L-spine
•
EOS classification:
•
T1-L3 = 75º
L3(+)P2
10
1/4/2014
Rib Support to slow parasol in SMA
Patient O.K.
Hybrid VEPTR
construct:
• Stryker 6 mm
Hooks on T3-T5
ribs
• S-hooks to pelvis
• Outriggers to
support parasol
deformity
Traditional Growth Rods
Get
Stiff Over Time
1.2
18
14
Gain (mm)
Change T1-S1 / Lengthening (cm)
1.0
16
Gain (mm)
? Smaller Effect
with VEPTR
0.8
12
10
0.6
8
6
4
0.4
2
0
Length 1
(n=36)
Length 2
(n=37)
Length 3
(n=38)
Length 4
(n=35)
Length 5
(n=26)
Length 6
(n=16)
Length 7
(n=8)
T1-S1 Gain vs. # of Lengthenings
0.2
0.0
L1-L5
L6-L10
L11-L15
But continued gain even at
L11-L15
2013: VEPTR as a growth rod
– Avoid spine = Avoid inadvertent fusion ?
– Safer in young children esp in (kyphoscoliosis)
– Preserve bone stock for later
– “Minimally Invasive” Surgery for Sick / Involved
Kids
– Easier to lengthen / lengthens in kyphotic segment
– Less stiffness at anchor  Less Hardware migration/
Rib Fracture?
11
1/5/2014
SUBMUSCULAR RODS
Laurel C. Blakemore, M.D.
Chief and Associate Professor, Pediatric Orthopaedics
Department of Orthopaedics and Rehabilitation
University of Florida College of Medicine
DISCOLSURES
• BSA
K2M
• consultant
K2M, Stryker
The Problem:
• Correcting or controlling a
progressive curve in a child
with significant growth
remaining
• Natural history of increased
mortality due to resp. failure
in early onset scoliosis
• Different etiologies present
different challenges
1
1/5/2014
The Ideal Instrument Would:
• Control alignment of
progressive curves
• modulate growth to decrease
curve over time (when
growth potential exists)
• Allow most normal growth of
spine and thorax
• Self-lengthen
• Leave spine flexible
Submuscular Rods
• Subcutaneous rods, “growing rods”
• Goals:
• Allow increase in trunk height while controlling
scoliosis
• Delay need for more extensive fusion
• Require lengthening every 6-12 months
(exc: OUS use – magnetic self-lengthening
rods)
Submuscular Rod Indications
• Progressive early onset scoliosis of
any etiology
• No expert consensus on
• Ideal age for initiation
•
but delay is preferable
• Threshold Cobb angle
• Lengthening interval
2
1/5/2014
Submuscular rod indications
• Size of Curvetypically >/=60 degrees
• Age  pref. over 4 but not past 9-10 y.o.
• delay with casting if possible (Fletcher JPO
2012- delayed GR placement by 39 mo)
• POSNA survey 2010 (Fletcher JPO 2011)
• most respondents would treat a progressive 70
deg idiopathic curve with growing rods
Maximum Cobb angle
correction at initial
surgery- correction does
not usually improve
Thompson &Akbarnia SRS 2004
• 28 pts
• 5 single rod w/ apical fusion
• 16 single rod
• 7 dual rod
• best Cobb correction and spinal growth (1.5
cm/yr) in dual rods
• worst in apical fusion group (final Cobb,
kyphosis, growth (0.3 cm/yr)
3
1/5/2014
Akbarnia et al 2008
•
•
•
•
13 pts dual growing rods
Cobb angle 81º-27º
46% complications- implant, infection
Growth 1.8 cm/yr (slightly higher than
expected normal) if 6 mo intervals
• Most studies have shown sl. lower growth
rates (1.2 cm/yr for standard as well as rib
to spine constructs)
Common Challenges in EOS systems
•
•
•
•
Profile of implants
Loss of fixation
Junctional Kyphosis
Autofusion
Implant Profile
• Must be as low as
possible!
• Small children
• submuscular position
• poor soft tissue coverage
• insensate (myelo, para)
• non-ambulatory
4
1/5/2014
Proximal Anchors
•
•
•
•
•
Hooks
Pedicle Screws
Wires
Tapes
Rib Fixation- hooks or tapes
Proximal loss of fixation
• Gradual w/ repeated
distractions vs acute
• Spine “grows away” from
rod vs hardware pullout
• Neurologic risk with
converging or single
screws in upper thoracic
Distal Fixation
• Hooks
• Pedicle screws
• Dunn-McCarthy
(‘S’ hooks)
• Iliac bolts (higher
rate of breakage,
Sponseller Spine 2009)
• S2AI screws
5
1/5/2014
Rod Breakage
• “Anticipated complication”
• Can see as a sign that spine
is still flexible
• Akbarnia pearl: replace both
rods, second rod is
weakened
Kyphosis
• Adds degree of difficulty!
• No current system solves
biomechanical challenge
• Posterior distraction of rods increases
kyphosing force
•
•
•
•
JBJS 2010
140 pts mean 5 yr f/u GSSG
Overall comp rate 58%
Complication risk increased by 24% for
each additional surgical procedure
6
1/5/2014
• Looked at complication rates for spinespine GR, rib-spine GR and VEPTR
• Overall 73% complication rate (2.3 per S-S,
.86 per R-S GR pt)
• One neurologic deficit (VEPTR)
• 38 pts 5 centers GSSG
• Suggests increased rate of
growth in the levels under
instrumentation (at least near
anchor points)
• Supports Akbarnia’s findings
• So why diminishing returns?
7
1/5/2014
JPO 2012
• ¼ showed clinically significant
abnormalities on psych testing
• 1/3 scored “at risk”
• esp. younger kids (more surgeries)
Growing-Rod Graduates: Lessons Learned from
Ninety-nine Patients Who Completed Lengthening
John M. Flynn, MD, Lauren A. Tomlinson, BS, Jeff Pawelek, BS, George H. Thompson, MD, Richard
McCarthy, MD, Behrooz A. Akbarnia, MD, and the Growing Spine Study Group
JBJS 2013
• Multicenter study, 99 pts at skeletal maturity
• 93% had undergone definitive fusion (12.9 yrs avg)
• correction minimal and spine described as
“completely stiff” in 62%
• same levels fused in 55%
Summary
• Growing rods result in an improvement on
the natural history of untreated EOS
• Pediatric deformity system needs versatility
to meet challenges of curve type and
etiology
• Still not good enough
8
1/4/2014
Current Concepts in Early Onset Scoliosis
Magnetically Controlled Growing Rods (MCGR )
Behrooz A. Akbarnia, MD
Clinical Professor, University of California, San Diego
EOS Program and clinic, Rady Children’s Hospital,
San Diego, California
VuMedi Seminar, January 6, 2014
MCGR (MAGEC) is not FDA approved and not commercially available in the United States
Disclosures (Growing Spine)
Growing Spine Foundation (a)
DePuy Spine (a,b)
Ellipse Tech. (a,b)
K2M (a,b)
Kspine (b)
a.
b.
c.
d.
e.
Grants/Research Support
Consultant
Stock/Shareholder
Speakers’ Bureau
Other Financial Support
Early Onset Spinal Deformity
Treating very
young children
with progressive
EOS remains
challenging…
1
1/4/2014
Natural History Untreated Scoliosis
•Infantile: 0 to 3 years
•Juvenile: 4 to 9 years
•Adolescent: 10 to 16 years
Pehrsson, Larssson, Oden & Nachemson, Spine,
1992
Challenges in EOS
•
•
•
•
•
Many etiologies
Many different treatments
High rate of complications
Limited outcome measures
Comparisons difficult!
Classification of EOS (C-EOS)
Etiology
Cobb
Angle
Congenital/
Structural
1: <20°
Neuromus
cular
2: 21-50°
Syndromic
3: 51-90°
Idiopathic
4: >90°
Vitale
Kyphosis
APR
Modifier
(-): <20°
P0: <10°/yr
N: 21-50°
P1: 10-20°/yr
(+): >50°
P2: >20°/yr
2
1/4/2014
Fusing scoliosis early may contribute to
shortening of the thoracic spine, TIS, and
respiratory insufficiency
• 28 pts, early thoracic fusion before the age 9 years,
– evaluated by pulmonary function testing at a minimum of 5 years f/u
– compared to age matched controls
• Average age at surgery was 3.3 yrs and at follow up was 14.6 yrs.
• Thoracic spinal height
< 18 cm
18 to 22 cm
22 cm to normal†
FVC < 50%
63% pts
25% pts
0% pts
13 cm
† normal 28 cm males, 26 cm females
Deceased
Karol, et al., JBJS 2008, 90: 1272-1281.
Growth Friendly Implant Classification
1. Distraction based
– Growing Rods
– VEPTR
– MCGR
2. Guided Growth
< age 8 ?
All
etiologies
< age
9?
ONLY VEPTR IS All etiologies
APPROVED in
USA
– Luque-Trolley
– Shilla
< age 9 ?
All etiologies
3. Tension Based
>age 8
Non-congenital
– Tether
– Staple
Skaggs
Shilla
Open Screws – no fusion
no bone exposed
allow rod to slide
multiaxial
3 level fusion
compression
distraction
derotation
Richard McCarthy
3
1/4/2014
Absent Ribs: Expansion
Thoracoplasty by Multiple Devices
Growing Rods
RESULTS (cont’d)
GROUP
Cobb Angle
Single with
apical
85° → 65 °
23%
Increase in
T1-S1
Length
6.4cm
Single w/o
apical
61° → 39 °
36%
7.6cm
Dual w/o
apical
92° → 26°
71%
11.8cm
(Pre-Initial to
Post Final)
%
Correction
4
1/4/2014
Growth per Year (cm)
•
•
•
•
•
Total Group
Under 5 years
5-10 year
Under treatment
Post final fusion group
1.21
1.19
1.13
1.01
1.66
Introduction
Growth modulation with current Growing Rod (GR)
techniques require frequent surgical lengthening and
has a high risk of complications
December 2010
• The complication risk increased by 24% for each additional
surgical procedure.
• Growth-guided procedures, may reduce the number of
procedures, but do not provide any distraction.
Early onset scoliosis treated with Growing Rods
has more growth and better Cobb correction but
more surgeries compared to Shilla
Lindsay M. Andras, MD 1; Elizabeth R. A. Joiner, BS1; Richard E. McCarthy, MD 2;
Scott J. Luhmann, MD 3; Paul D. Sponseller, MD 4; John B. Emans 5, MD;
David L. Skaggs, MD 1 and Growing Spine Study Group
•
•
•
•
•
37 GR 37 Shilla
Same FU (4.1 vs 4.6)
T1-S1 ( 8.5 vs 6.4)
Cobb angle Change ( 36 vs 23)
Number of surgeries (7 vs 2.8)
ICEOS 2012
5
1/4/2014
Magnetically Controlled
Growing Rod
(MCGR)
Phenix
MAGEC
MCGR is not
commercially
available in the
United States
Introduction
• The use of remotely controlled
lengthening devices has been
previously reported. (Takaso
et al., Soubeiran et al.)
• Goal of MCGR: To reduce
frequency of surgeries while
still providing distraction
MCGR (MAGEC) Technology
Rare Earth Magnets
Neodymium Iron Boron (NdFeB)
Rotational Force
Axial Force
The interaction between the internal implant magnets and external
remote controller magnets are used to non-invasively adjust implant
dimensions.
6
1/4/2014
MCGR Technology
MAGEC
Implantable spinal rod
with magnetic actuator
External remote controller
non-invasive adjustment
Example of current
physician directed
adjustable rod.
Requires surgical
intervention for
adjustment
Remote Distraction
JOHN FERGUSON FRACS
INTRODUCTION
• Magentically controlled growing rods (MCGR) were
developed to allow for non-invasive lengthening
• Pre-clinical studies has shown promising results
Spine 2012
7
1/4/2014
CONCLUSIONS
-------------------------------------• MCGR was shown to be safe and effective in this
study
• No complication resulted directly from distraction
• MCGR distinguishes itself by:
• Distraction accuracy / prediction
• Ability to shorten
• This study was designed to evaluate the
safety and efficacy of the MCGR technique in
patients with early onset scoliosis
Materials and Methods
T1-T12
T1-S1
Actuator expansion
• 14 patients met the inclusion criteria
(1) EOS of any etiology
(2) Minimum of 3 distractions
Instrumented height of the spine
• 33 MCGR patients in 4 centers (Hong
Kong, London, Cairo and Ankara)
• T1-T12, T1-S1 and height of
instrumented spine was measured
8
1/4/2014
Materials and Methods
Etiology
• 14 patients:(7 M, 7 F)
• Mean age: 8 y+10 m
(3 y+6 m to 12 y+7 m)
Idiopathic
Neuromuscular
Congenital
Syndromic
NF
7%
14%
• 14 initial surgeries
• 68 distractions
36%
14%
29%
Results
• 5 single rod (SR) and 9 dual rod (DR)
• Average of 10 months follow up (6-18).
• An average of 4.9 distractions per patient
• Mean interval between index MCGR and the
first distraction was 66 days
• Mean interval between two subsequent
distractions was 43 days
Results - Mean Monthly T1-S1 Height Change
MCGR Single Rod
MCGR Dual Rod
Dimeglio 5-10 years
Original GR (Akbarnia)
Dimeglio 0-5 years
3.09 mm
2 mm
P<0.05
1.27 mm
N=5
1.2 mm
N=9
1.22 mm
N=23
Mean Monthly T1-S1 Height Change (mm/mo)
9
1/4/2014
Case one:
5.5 y/o Female (NM)
Pre Index
Post Index
45°
21°
T1-T12: 176 mm
T1-S1: 251 mm
∆T1-T12: 5 mm
∆T1-S1:10 mm
T1-T12: 181 mm
T1-S1: 261 mm
Case one: A 5.5 y/o NM female
Latest Follow up
Post Index
21°
9°
T1-T12: 181 mm
T1-S1: 261 mm
∆T1-T12: 11 mm
∆T1-S1: 31 mm
T1-T12: 193 mm
T1-S1: 292 mm
Comparison Data
Pre-operative
Most recent
Result
GSSG Data (average follow up 28 months)
Cobb Angle (°)
77.6 ± 16.7
41.3 ± 16.6
47% deformity
correction
Thoracic Spine
Height (mm)
165.6 ± 22.1
203.5 ± 27.5
23% Increased
thoracic spine height
MAGEC Data (average follow up 7.6 months)
Cobb Angle (°)
58.8 ± 12.3
31.4 ± 9.3
47% deformity
correction
Thoracic Spine
Height (mm)
186 ± 28
212 ± 28
14% Increased
thoracic spine height
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1/4/2014
Lancet April 2012
• Five patients, 2 with over 24 months follow up
Scoliosis
Spinal Growth
MCGR (Case 1)
MCGR (Case 1)
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1/4/2014
MCGR (Case 2)
Pre Op AP
Post Op AP
MCGR- Case 2
14.5 mm
12.3 mm
Post Distraction June 2010
Courtesy of Ken Cheung, MD, University of Hong Kong, HK
INTRODUCTION
2012-13
• Early clinical results of MCGR:
- Safe and effective
- Significant reduction in the number of surgical procedures
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1/4/2014
Traditional Growing Rods Versus Magnetically
Controlled Growing Rods in Early Onset Scoliosis:
A Case-Matched Two Year Study
B. A. Akbarnia, K. Cheung, G. Demirkiran, H. Elsebaie
J. Emans, C. Johnston, G. Mundis, H. Noordeen, J. Pawelek
M. Shaw, D. Skaggs, P. Sponseller, G. Thompson, M. Yazici,
Growing Spine Study Group
48th Annual Meeting of Scoliosis Research Society
September 18-21, 2013 – Lyon, France
INTRODUCTION
• The purpose of this study was to perform a
case-matched comparison of MCGR and TGR
patients with 2 years of follow-up
MCGR
TGR
METHODS
• Retrospective review of MCGR patients who met the
following criteria:
-
< 10 years old
Major curve >30º
No previous spine surgery
> 2-year follow-up
• 17 MCGR patients met the inclusion criteria
• 12 of 17 patients had complete data available for
analysis
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1/4/2014
METHODS
• Each MCGR patient was matched to a TGR patient by:
-
Etiology
Gender
Single vs. dual rods
Pre-op age (+/-10 months)
Pre-op major curve (+/- 20º)
• Etiologies were classified per C-EOS (Vitale):
-
Idiopathic
Congenital/Structural
Neuromuscular
Syndromic
• One male MCGR patient was matched to a female TGR
patient since a male-male match could not be found
METHODS
Spinal growth calculation: “Annual T1-S1 Growth”
Annual T1-S1
Growth
(mm/year)
=
Δ in T1-S1 from post index to latest F/U
Length of follow-up
RESULTS
• MCGR patients:
- Mean age = 6.8 years
- Mean follow-up = 2.5 years
• Follow-up was greater for TGR patients by 1.6 years
• Distribution of etiologies:
- 4 Neuromuscular
- 4 Syndromic
- 3 Idiopathic
- 1 Congenital
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RESULTS
Major
Curve
T1-S1
Spinal
Length
Pre-op
(mean)
Post-op
(mean)
>2 Yr Post-op
(mean)
Overall
Change
MCGR
59°
32°
38°
35%
TGR
60°
31°
41°
32%
MCGR
270 mm
295 mm
307 mm
38 mm
TGR
264 mm
311 mm
347 mm
77 mm
p=0.01
RESULTS
• Overall curve correction
– Similar between groups throughout treatment (p>0.1)
• Overall increase in T1-S1
– Greater in TGR compared to MCGR (p=0.01)
– Possibly due to additional follow up of TGR patients (1.6
years)
• Annual T1-S1 growth
– 7 mm/year for MCGR
– 11 mm/year for TGR patients
– This difference did not reach statistical significance due to
sample size (minimum 10 mm/year to show significance)
RESULTS (Procedures)
Total Open
Surgeries
MCGR
16
TGR
78
Total
Lengthenings
137
(non-invasive)
49
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1/4/2014
RESULTS (Procedures)
Implant
Complications
Wound
Complications
Medical
Complications
Number of
Revisions
MCGR
10
1
3
4
TGR
15
3
5
23
•
MCGR revisions included: anchor pull out, prominent implants and
collapse of device (all cases were generation 1 devices)
•
TGR revisions included: anchor pull out, rod breakage, prominent
implants, planned surgery to exchange connector
Compassionate Use in U.S.
8+11 year old boy with Idiopathic EOS
Compassionate Use in U.S.
8+11 year old boy with Idiopathic EOS
top
right
left
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1/4/2014
Compassionate Use in U.S.
8+11 year old boy with Idiopathic EOS
top
right
left
Summary MCGR
• Major curve correction was similar between MCGR
and TGR patients throughout treatment
• Overall gain in T1-S1 was greater in TGR compared to
MCGR, however, TGR had longer follow-up
• MCGR patients had 62 fewer surgical procedures than
TGR patients and more non-invasive lengthenings
• Need to build consensus and develop practice
guidelines for non-invasive lengthenings to reduce
surgeon variability and improve reproducibility
• Early results promising but Longer follow up and larger
multicenter studies needed
THANK YOU
8th
Nov. 20-21, 2014
Warsaw,
Poland
17