Casting. Early Onset Scoliosis: The Value of Serial Risser Casts. Serial Risser Casts 1/4/2014

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1 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

2 Protocol RBCH Pediatric Orthopaedic Spine Database Indications for Risser casting ( ) 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

3 Longitudenal traction Iliac mold Infantile idiopathic scoliosis - Risser cast 3

4 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, ) Months in cast 15.8±8.9 months (range, 4 35 months) Major curve at treatment change 49±27 (range, ) 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

5 81 27 Pre-cast 2+1 yrs 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

6 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 10 o ) 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 o 27.5cm GR o 26.0cm p Diagnosis IIS/JIS 9 N-M 6 Synd 10 Diagnosis pairs closely matched Curve magnitude -> surgical! 6

7 Final followup Results Outcome Duration Treatment Cobb T1-S1 T1-S1 Cast 2.4 yrs cm 3.3cm GR 4.5 yrs cm 5.6cm P Mean # of treatments Casts 3.9 GR lengthen 5.6 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 f/u) Required longer duration of treatment + 6 lengthenings to achieve 11 /25 (44%) pts. suffered 23 complications 7

8 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

9 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 -Disclosures- Michael 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

10 Consider Surgical Stabilization for Progressive Curves Before They Get Too Large Etiology Cobb Angle (Major Curve) Maximum Total Kyphosis Progression Modifier (optional) Highest Congenital/Structural 1: <20 (-) <20º P0: <10 / yr Lowest Priority Neuromuscular Syndromic Idiopathic 2: : : 90 N: (+): 50 P1:10-19 / yr 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 yrs: 1.3 cm/yr - Dimeglio % Normal Ht 2

11 Patients With < 17 cm of T1=T12 Height Have Better Lung Function Johnston et al, J Bone Joint Surg Am 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

12 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

13 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

14 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

15 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

16 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 9/06 Spastic paraparesis, urinary retention 5 mo after last uneventful lengthening 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

17 Patient TO 18 month old girl Jehovah s Witness Horizontal 3/2005 Gaze Palsy 3/2005 Patient TO: Intra-Operative Correction with Rib/Pedicle Hybrid 3/ wk post-op TO: Conversion to VEPTR 9 Lengthenings 3/2005, 18mo old The beginning 3/2009, 6 yrs old Getting There 9

18 Staged Revision to Spine -Jehova s Witness 8/2010 5/ yo Rib Support to slow parasol in SMA Patient EW: VEPTR T2 to Pelvis Hybrid for SMA T6-L4 84 T8-L4 46 Pre-operative 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 T1-L3 = 75º EOS classification: L3(+)P2 10

19 Gain (mm) 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 Gain (mm) Traditional Growth Rods Get Stiff Over Time 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 ? Smaller Effect with VEPTR Change T1-S1 / Lengthening (cm) L1-L5 L6-L10 L11-L15 But continued gain even at L11-L : 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

20 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

21 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

22 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 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 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

23 1/5/2014 Akbarnia et al 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

24 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

25 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 pts mean 5 yr f/u GSSG Overall comp rate 58% Complication risk increased by 24% for each additional surgical procedure 6

26 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

27 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

28 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. Grants/Research Support b. Consultant c. Stock/Shareholder d. Speakers Bureau e. Other Financial Support Early Onset Spinal Deformity Treating very young children with progressive EOS remains challenging 1

29 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) Vitale Etiology Cobb Angle Kyphosis APR Modifier Congenital/ Structural 1: <20 (-): <20 P 0 : <10 /yr Neuromus cular 2: N: P 1 : /yr Syndromic 3: Idiopathic 4: >90 (+): >50 P 2 : >20 /yr 2

30 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 FVC < 50% < 18 cm 63% pts 18 to 22 cm 25% pts 22 cm to normal 0% pts 13 cm normal 28 cm males, 26 cm females Deceased Karol, et al., JBJS 2008, 90: Growth Friendly Implant Classification 1. Distraction based Growing Rods VEPTR MCGR 2. Guided Growth Luque-Trolley Shilla ONLY VEPTR IS APPROVED in USA < age 8? All < age etiologies 9? All etiologies < age 9? All etiologies 3. Tension Based Tether Staple Skaggs >age 8 Non-congenital Open Screws no fusion no bone exposed allow rod to slide multiaxial Shilla 3 level fusion compression distraction derotation Richard McCarthy 3

31 Absent Ribs: Expansion Thoracoplasty by Multiple Devices Growing Rods RESULTS (cont d) GROUP Single with apical Single w/o apical Dual w/o apical Cobb Angle (Pre-Initial to Post Final) % Correction % 6.4cm % 7.6cm Increase in T1-S1 Length % 11.8cm 4

32 Growth per Year (cm) Total Group 1.21 Under 5 years year 1.13 Under treatment 1.01 Post final fusion group 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, BS 1 ; 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

33 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

34 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

35 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 33 MCGR patients in 4 centers (Hong Kong, London, Cairo and Ankara) 14 patients met the inclusion criteria (1) EOS of any etiology (2) Minimum of 3 distractions Actuator expansion Instrumented height of the spine T1-S1 T1-T12 T1-T12, T1-S1 and height of instrumented spine was measured 8

36 Materials and Methods 14 patients:(7 M, 7 F) Mean age: 8 y+10 m (3 y+6 m to 12 y+7 m) Etiology Idiopathic Neuromuscular Congenital Syndromic NF 14 initial surgeries 68 distractions 14% 14% 7% 36% 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 0-5 years Dimeglio 5-10 years Original GR (Akbarnia) 3.09 mm 1.27 mm P< mm 1.2 mm 1.22 mm N=5 N=9 N=23 Mean Monthly T1-S1 Height Change (mm/mo) 9

37 Case one: Pre Index 5.5 y/o Female (NM) Post Index 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 Post Index Latest Follow up 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 ± ± % deformity correction Thoracic Spine Height (mm) ± ± % Increased thoracic spine height MAGEC Data (average follow up 7.6 months) Cobb Angle ( ) 58.8 ± ± % deformity correction Thoracic Spine Height (mm) 186 ± ± 28 14% Increased thoracic spine height 10

38 Lancet April 2012 Five patients, 2 with over 24 months follow up Scoliosis Spinal Growth MCGR (Case 1) MCGR (Case 1) 11

39 MCGR (Case 2) Pre Op AP Post Op AP MCGR- Case mm 12.3 mm Post Distraction June 2010 Courtesy of Ken Cheung, MD, University of Hong Kong, HK INTRODUCTION Early clinical results of MCGR: - Safe and effective - Significant reduction in the number of surgical procedures 12

40 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 48 th Annual Meeting of Scoliosis Research Society September 18-21, 2013 Lyon, France The purpose of this study was to perform a case-matched comparison of MCGR and TGR patients with 2 years of follow-up TGR INTRODUCTION MCGR 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 13

41 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 14

42 RESULTS Pre-op (mean) Post-op (mean) >2 Yr Post-op (mean) Overall Change Major Curve MCGR TGR % 32% T1-S1 Spinal Length MCGR 270 mm 295 mm 307 mm TGR 264 mm 311 mm 347 mm 38 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 Total Lengthenings MCGR (non-invasive) TGR

43 RESULTS (Procedures) Implant Complications Wound Complications Medical Complications Number of Revisions MCGR TGR 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 year old boy with Idiopathic EOS Compassionate Use in U.S year old boy with Idiopathic EOS top right left 16

44 Compassionate Use in U.S 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 , 2014 Warsaw, Poland 17