Financial Disclosures. The Unpredictable. Early Onset Idiopathic Scoliosis

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Financial Disclosures Vertebral body stapling in children with idiopathic scoliosis < 10 years of age with curve magnitude 30-39 degrees Alexander A. Theologis, MD; Patrick Cahill, MD; Mike Auriemma, BS; Randal Betz, MD; Mohammad Diab, MD 58 th Annual LeRoy C. Abbott Society Scientific Program 34 th Annual Verne T. Inman Lectureships Theologis: none Cahill: DePuy Synthes Spine Auriemma: none Betz: Medtronic, DePuy Synthes Spine, Orthocon, SpineGuard, MiMedx Diab: none Department of Orthopaedic Surgery, UCSF March 11, 2013 Early Onset Idiopathic Scoliosis Skeletally immature child Infantile: < 3 years Juvenile: 3-10 years Challenging Growth potential? Age Curve magnitude Unpredictable The Unpredictable Mild Moderate Severe <25 25 45 degrees > 45 degrees Management? - Prevent curve progression - Prevent surgical fusion 1

Observation vs. Bracing Nonoperative Conflicting data No difference in surgical rates (22% vs. 23%) (Dolan et al. 2007) Curve magnitude at onset of puberty is the only important factor (DiMeglio 2011) Cobb angle < 20 20-30 > 30 Risk of fusion 16% 75% 100% The Dilemma < 10 years old with curves > 30 degrees Curve too severe to be controlled with a brace Patient too young to be fused Crankshaft phenomenon Limit growth of spine Fusionless surgical alternatives? Improve curve Prevent progression & fusion Vertebral body stapling VBS Adopted from long bone growth modulation (Blount) First use 1954: congenital scoliosis (Smith) Nitinol staples Shape memory alloy Cold: straight prongs Warm: curved prongs Evolution Indications Age < 13 (girls); < 15 (boys) Thoracic curves: < 35 degrees Lumbar curves: 25-45 degrees 2

Literature Betz et al. 2003 21 pts (11.9 yrs; 10-14 years) Thoracic: 60% success for 18 to 55 curves (minimum 1 year f/u) Betz et al. 2010 28 pts (9.4 yrs; 4-13); minimum 2 year f/u Lumbar: 87% success for 25 to 45 curves Thoracic: 79% success for 25 to 35 curves Laituri et al. Thoracic: 71.4% success for curves 25 to 41 Thoracoscopic only 7 children (8-11 years old) Objective To determine whether VBS may arrest or slow curve progression in order to avoid fusion in children < 10 years of age with scoliosis 30 to 39 30 to 39. Improved success with narrower curve magnitudes and/or age criteria? Retrospective case series UCSF Shriner s Philadelphia Methods Open Surgical technique Inclusion < 10 years old Idiopathic scoliosis Cobb angle 30 39 degrees Minimum 2 year follow-up Outcome variables Intra-operative and hospital data Complications Definitive fusion for curve progression (greater than 10 degrees) Need for re-operation for any indication Thoracoscopic 3

Patients Operative Data Results Curve progression Thoracic: 0% Lumbar: 0% Need for fusion: 0% Revision surgery: 0% 4

Conclusions Children < 10 years old with idiopathic scoliosis 30 to 39 may significantly benefit from immediate VBS without observation or bracing. This treatment may ultimately prevent the need for surgical fusion at a later age. Unknowns! Lower age limit? Children between 10 and puberty? Effect on growth? Overcorrection? Larger curves (>40-45 )? Vertebral tethering Larger curves Original use in the lumbar spine as a dynamic stabilizer Titanium pedicle screws Polyethylene flexible tether: compresses adjacent screws when tightened Vertebral tethering Future Directions 48 17 43 20 Exciting! The future Biomechanical comparisons Surgical indications? (age, curves, etc) Larger cohorts Longer follow-up Patient outcomes 4 yo 58 5

References 1. Smith AD, Von Lackum WH, Wylie R. An operation for stapling vertebral bodies in congenital scoliosis. J Bone Joint Surg Am 1954;36:342-8. 2. Dolan LA, Weinstein SL. Surgical rates after observation and bracing for adolescent idiopathic scoliosis: an evidence-based review. Spine (Phila Pa 1976) 2007;32:S91-S100. 3. Charles YP, Daures JP, de Rosa V, et al. Progression risk of idiopathic juvenile scoliosis during pubertal growth. Spine (Phila Pa 1976) 2006;31:1933-42. 4. DiMeglio A, Canavese F, Charles YP. Growth and adolescent idiopathic scoliosis: when and how much? J Pediatr Orthop 2011;31:S28-36. 5. Zuege RC, Kempken TG, Blount WP. Epiphyseal stapling for angular deformityat the knee. J Bone Joint Surg Am 1979;61:320 9. 6. Laituri CA, Schwend RM, Holcomb GW, 3rd. Thoracoscopic vertebral body stapling for treatment of scoliosis in young children. J Laparoendosc Adv Surg Tech A 2012;22:830-3. 7. Betz RR, Ranade A, Samdani AF, et al. Vertebral body stapling: a fusionless treatment option for a growing child with moderate idiopathic scoliosis. Spine (Phila Pa 1976) 2010;35:169-76. 8. Betz RR, D'Andrea LP, Mulcahey MJ, et al. Vertebral body stapling procedure for the treatment of scoliosis in the growing child. Clin Orthop Relat Res 2005:55-60. 9. Betz RR, Kim J, D'Andrea LP, et al. An innovative technique of vertebral body stapling for the treatment of patients with adolescent idiopathic scoliosis: a feasibility, safety, and utility study. Spine (Phila Pa 1976) 2003;28:S255-65. 10. Lavelle WF, Samdani AF, Cahill PJ, et al. Clinical outcomes of nitinol staples for preventing curve progression in idiopathic scoliosis. J Pediatr Orthop 2011;31:S107-13. 11. Trobisch PD, Samdani A, Cahill P, et al. Vertebral body stapling as an alternative in the treatment of idiopathic scoliosis. Oper Orthop Traumatol 2011;23:227-31. 12. Betz et al. VBS Biomechanics Fusionless Alternatives Growing rods Shilla VEPTR 1) Staple placement restricts ROM in axial rotation and lateral bending 2) There is no mechanical difference between one double-prong staple and 2 single-prong staples 3) An anterior staple significantly reduces the overall flexion-extension ROM of the thoracic spine. 4) Staple fixation does not result in significantly elevated adjacent segment motion. High complication rate Broken rods Infection Multiple surgeries Cost 6