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A high degree of variability exists in how “safety and efficacy” is defined and reported in growing rod surgery for early onset scoliosis: a systematic review

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Abstract

Summary

Established criteria for reporting safety and efficacy have not yet been defined in growing rod surgery for early onset scoliosis. A systematic literature review revealed a high degree of variability in how authors stratified complications and patient outcomes as a means to define safety and efficacy for this challenging patient population.

Introduction

Several publications have reported the safety and efficacy of traditional growing rods (TGR) and magnetically controlled growing rods (MCGR) using various parameters. Radiographic parameters are most commonly used to measure efficacy, while incidence and type of complications are used to assess safety. A systematic review of peer-reviewed articles was performed to identify whether a consensus exists in how safety and efficacy parameters are reported in EOS patients treated with TGR and MCGR.

Hypothesis

There is no consensus on the parameters used for reporting safety and efficacy in growing rod treatment for early onset scoliosis.

Study design

Systematic literature review.

Methods

Four databases were searched on November 10, 2016 to identify all qualified peer-reviewed articles using specific keyword searches. All peer-reviewed articles published in English language reporting any data related to safety and efficacy of the TGR and/or MCGR surgical technique were included. Articles that met the inclusion criteria were scored by modified Downs and Black scoring system (J Epidemiol Community Health 52(6):377–384, 1998) for non-randomized studies. All reported safety and efficacy data were extracted and analyzed.

Results

Search of the databases resulted in 111 unique citations including: PubMed (50), Embase (68 with 21 duplicates), Web of Science (29 with 15 duplicates), and CINAHL (15; all duplicates). Fifty-six of 111 citations were excluded during the review of the titles and abstracts. In addition, 16 citations were excluded at the time of full manuscript review. The remaining 39 articles included 23 TGR (2007–2016) and 16 MCGR papers (2012–2016). The overall Downs and Black score was 63.9 for TGR papers vs. 64.0 for MCGR papers (p = 0.97). Efficacy measures were not consistently reported among the publications. The only consistently reported efficacy parameter in majority (> 90%) of papers was curve size. Complication reporting was highly variable.

Conclusion

Major curve size was the only consistent parameter to report efficacy in peer-reviewed TGR and MCGR publications. Since complications were not consistently reported, assessing safety of either treatment was infeasible. Establishing standardized safety and efficacy parameters in growing rod surgery for EOS would improve the quality of future studies and makes comparison of different treatment modalities possible. Indeed, other clinically relevant parameters such as health-related quality of life, pulmonary function, nutritional status, and psychiatric and developmental health should also be considered to improve the future safety and efficacy reporting.

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References

  1. Akbarnia BA, Marks DS, Boachie-Adjei O, Thompson AG, Asher MA (2005) Dual growing rod technique for the treatment of progressive early-onset scoliosis: a multicenter study. Spine 30(17 Suppl):S46–S57

    Article  PubMed  Google Scholar 

  2. Banta HD (1978) Assessing the efficacy and safety of medical technologies. In: (OTA) TOoTA (ed) Superintendent of documents, US Government Printing Office. Washington, D.C.

  3. Klemme WR, Denis F, Winter RB, Lonstein JW, Koop SE (1997) Spinal instrumentation without fusion for progressive scoliosis in young children. J Pediatr Orthop 17(6):734–742

    CAS  PubMed  Google Scholar 

  4. Downs SH, Black N (1998) The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. J Epidemiol Community Health 52(6):377–384

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  5. West S, King V, Carey TS, Lohr KN, McKoy N, Sutton SF et al (2002) Systems to rate the strength of scientific evidence. Evid Rep Technol Assess (Summary) 47:1–11

    Google Scholar 

  6. Deeks JJ, Dinnes J, D’Amico R, Sowden AJ, Sakarovitch C, Song F et al (2003) Evaluating non-randomised intervention studies. Health Technol Assess (Winchester, England) 7(27):iii–x, 1–173

  7. Akbarnia BA, Breakwell LM, Marks DS, McCarthy RE, Thompson AG, Canale SK et al (2008) Dual growing rod technique followed for three to eleven years until final fusion: the effect of frequency of lengthening. Spine 33(9):984–990

    Article  PubMed  Google Scholar 

  8. Behrooz A. Akbarnia JBP, Kenneth MC, Demirkiran CG, Elsebaie H, Emans JB, Johnston CE, Mundis GM, Noordeen H, Skaggs D, Sponseller P, Thompson G, Yaszay B, Yazici M (2014) Traditional growing rods versus magnetically controlled growing rods for the surgical treatment of early-onset scoliosis: a case-matched 2-year study. Spine Deform 2(6):493–497

  9. Akgul T, Dikici F, Sar C, Talu U, Domanic U (2014) Growing rod instrumentation in the treatment of early onset scoliosis. Acta Orthop Belg 80(4):457–463

    PubMed  Google Scholar 

  10. Bess S, Akbarnia BA, Thompson GH, Sponseller PD, Shah SA, El Sebaie H et al (2010) Complications of growing-rod treatment for early-onset scoliosis: analysis of one hundred and forty patients. J Bone Joint Surg Am Vol 92(15):2533–2543

    Article  Google Scholar 

  11. Chandran S, McCarthy J, Noonan K, Mann D, Nemeth B, Guiliani T (2011) Early treatment of scoliosis with growing rods in children with severe spinal muscular atrophy: a preliminary report. J Pediatr Orthop 31(4):450–454

    Article  PubMed  Google Scholar 

  12. Elsebai HB, Yazici M, Thompson GH, Emans JB, Skaggs DL, Crawford AH et al (2011) Safety and efficacy of growing rod technique for pediatric congenital spinal deformities. J Pediatr Orthop 31(1):1–5

    Article  PubMed  Google Scholar 

  13. Farooq N, Garrido E, Altaf F, Dartnell J, Shah SA, Tucker SK et al (2010) Minimizing complications with single submuscular growing rods: a review of technique and results on 88 patients with minimum two-year follow-up. Spine 35(25):2252–2258

    Article  PubMed  Google Scholar 

  14. Greggi T, Lolli F, Di Silvestre M, Martikos K, Vommaro F, Maredi E et al (2012) Complications incidence in the treatment of early onset scoliosis with growing spinal implants. Stud Health Technol Inf 176:334–337

    CAS  Google Scholar 

  15. Kamaci S, Demirkiran G, Ismayilov V, Olgun ZD, Yazici M (2014) The effect of dual growing rod instrumentation on the apical vertebral rotation in early-onset idiopathic scoliosis. J Pediatr Orthop 34(6):607–612

    Article  PubMed  Google Scholar 

  16. Caniklioglu M, Gokce A, Ozturkmen Y, Gokay NS, Atici Y, Uzumcugil O (2012) Clinical and radiological outcome of the growing rod technique in the management of scoliosis in young children. Acta Orthopaed Traumatol Turcica 46(5):379–384

    Google Scholar 

  17. Li WJ, Sun ZJ, Guo SG, Qiu GX, Zhang JG, Shen JX et al (2016) The effect of growing Rod treatment on coronal balance during serial lengthening surgeries in early onset scoliosis. BMC Musculoskelet Disord 17:158

    Article  PubMed  PubMed Central  Google Scholar 

  18. McElroy MJ, Shaner AC, Crawford TO, Thompson GH, Kadakia RV, Akbarnia BA et al (2011) Growing rods for scoliosis in spinal muscular atrophy: structural effects, complications, and hospital stays. Spine 36(16):1305–1311

    Article  PubMed  Google Scholar 

  19. McElroy MJ, Sponseller PD, Dattilo JR, Thompson GH, Akbarnia BA, Shah SA et al (2012) Growing rods for the treatment of scoliosis in children with cerebral palsy: a critical assessment. Spine 37(24):E1504–E1510

    Article  PubMed  Google Scholar 

  20. Sankar WN, Acevedo DC, Skaggs DL (2010) Comparison of complications among growing spinal implants. Spine 35(23):2091–2096

    Article  PubMed  Google Scholar 

  21. Sankar WN, Skaggs DL, Yazici M, Johnston CE 2nd, Shah SA, Javidan P et al (2011) Lengthening of dual growing rods and the law of diminishing returns. Spine 36(10):806–809

    Article  PubMed  Google Scholar 

  22. Schroerlucke SR, Akbarnia BA, Pawelek JB, Salari P, Mundis GM Jr, Yazici M et al (2012) How does thoracic kyphosis affect patient outcomes in growing rod surgery? Spine 37(15):1303–1309

    Article  PubMed  Google Scholar 

  23. Sponseller PD, Thompson GH, Akbarnia BA, Glait SA, Asher MA, Emans JB et al (2009) Growing rods for infantile scoliosis in Marfan syndrome. Spine 34(16):1711–1715

    Article  PubMed  Google Scholar 

  24. Sun ZJ, Qiu GX, Zhao Y, Guo SG, Zhang JG, Shen JX et al (2015) Dual growing rod treatment in early onset scoliosis: the effect of repeated lengthening surgeries on thoracic growth and dimensions. Eur Spine J 24(7):1434–1440

    Article  PubMed  Google Scholar 

  25. Thompson GH, Akbarnia BA, Campbell RM Jr (2007) Growing rod techniques in early-onset scoliosis. J Pediatr Orthop 27(3):354–361

    Article  PubMed  Google Scholar 

  26. Wang S, Zhang J, Qiu G, Wang Y, Li S, Zhao Y et al (2012) Dual growing rods technique for congenital scoliosis: more than 2 years outcomes: preliminary results of a single center. Spine 37(26):E1639–E1644

    Article  PubMed  Google Scholar 

  27. Yang JS, Sponseller PD, Thompson GH, Akbarnia BA, Emans JB, Yazici M et al (2011) Growing rod fractures: risk factors and opportunities for prevention. Spine 36(20):1639–1644

    Article  PubMed  Google Scholar 

  28. Zhao Y, Qiu GX, Wang YP, Zhang JG, Shen JX, Li SG et al (2012) Comparison of initial efficacy between single and dual growing rods in treatment of early onset scoliosis. Chin Med J 125(16):2862–2866

    PubMed  Google Scholar 

  29. Akbarnia BA, Cheung K, Noordeen H, Elsebaie H, Yazici M, Dannawi Z et al (2013) Next generation of growth-sparing techniques: preliminary clinical results of a magnetically controlled growing rod in 14 patients with early-onset scoliosis. Spine 38(8):665–670

    Article  PubMed  Google Scholar 

  30. Cheung KM, Cheung JP, Samartzis D, Mak KC, Wong YW, Cheung WY et al (2012) Magnetically controlled growing rods for severe spinal curvature in young children: a prospective case series. Lancet 379(9830):1967–1974

    Article  PubMed  Google Scholar 

  31. Cheung JP, Samartzis D, Cheung KM (2014) A novel approach to gradual correction of severe spinal deformity in a pediatric patient using the magnetically-controlled growing rod. Spine J 14(7):e7–e13

    Article  PubMed  Google Scholar 

  32. Choi E, Yazsay B, Mundis G, Hosseini P, Pawelek J, Alanay A et al (2016) Implant complications after magnetically controlled growing rods for early onset scoliosis: a multicenter retrospective review. J Pediatr Orthop

  33. Dannawi Z, Altaf F, Harshavardhana NS, El Sebaie H, Noordeen H (2013) Early results of a remotely-operated magnetic growth rod in early-onset scoliosis. Bone Joint J 95-b(1):75–80

    Article  CAS  Google Scholar 

  34. Hickey BA, Towriss C, Baxter G, Yasso S, James S, Jones A et al (2014) Early experience of MAGEC magnetic growing rods in the treatment of early onset scoliosis. Eur Spine J 23(Suppl 1):S61–S65

    Article  PubMed  Google Scholar 

  35. Hosseini P, Pawelek J, Mundis GM, Yaszay B, Ferguson J, Helenius I et al (2016) Magnetically controlled growing rods for early-onset scoliosis: a multicenter study of 23 cases with minimum 2 years follow-up. Spine 41(18):1456–1462

    Article  PubMed  Google Scholar 

  36. Jones CS, Stokes OM, Patel SB, Clarke AJ, Hutton M (2015) Actuator pin fracture in magnetically controlled growing rods: two cases. Spine J

  37. Keskinen H, Helenius I, Nnadi C, Cheung K, Ferguson J, Mundis G et al (2016) Preliminary comparison of primary and conversion surgery with magnetically controlled growing rods in children with early onset scoliosis. Eur Spine J 25(10):3294–3300

    Article  PubMed  Google Scholar 

  38. Yoon WW, Sedra F, Shah S, Wallis C, Muntoni F, Noordeen H (2014) Improvement of pulmonary function in children with early-onset scoliosis using magnetic growth rods. Spine 39(15):1196–1202

    Article  PubMed  Google Scholar 

  39. Heydar AM, Sirazi S, Bezer M (2016) Magnetic controlled growing rods (MCGR) as a treatment of early onset scoliosis (EOS): Early results with two patients had been fused. Spine

  40. La Rosa G, Oggiano L, Ruzzini L (2017) Magnetically controlled growing rods for the management of early-onset scoliosis: a preliminary report. J Pediatr Orthop 37(2):79–85

    Article  PubMed  Google Scholar 

  41. Ridderbusch K, Rupprecht M, Kunkel P, Hagemann C, Stucker R (2016) Preliminary results of magnetically controlled growing rods for early onset scoliosis. J Pediatr Orthop

  42. Thompson W, Thakar C, Rolton DJ, Wilson-MacDonald J, Nnadi C (2016) The use of magnetically-controlled growing rods to treat children with early-onset scoliosis: early radiological results in 19 children. Bone Joint J 98-b(9):1240–1247

    Article  CAS  Google Scholar 

  43. Rolton D, Thakar C, Wilson-MacDonald J, Nnadi C (2016) Radiological and clinical assessment of the distraction achieved with remotely expandable growing rods in early onset scoliosis. Eur Spine J 25(10):3371–3376

    Article  CAS  PubMed  Google Scholar 

  44. Watanabe K, Uno K, Suzuki T, Kawakami N, Tsuji T, Yanagida H et al (2013) Risk factors for complications associated with growing-rod surgery for early-onset scoliosis. Spine. 38(8):E464–E468

    Article  PubMed  Google Scholar 

  45. Watanabe K, Uno K, Suzuki T, Kawakami N, Tsuji T, Yanagida H et al (2016) Risk factors for proximal junctional kyphosis associated with dual-rod growing-rod surgery for early-onset scoliosis. Clin Spine Surg 29(8):E428–E433

    Article  PubMed  Google Scholar 

  46. Hosseini P, Nnadi C, Rehak L, Repko M, Grevitt M, Aydinli U et al (2016) Analysis of segmental mobility following a novel posterior apical short-segment correction for adolescent idiopathic scoliosis. Spine 41(20):E1223-e9

    Article  Google Scholar 

  47. Smith JT, Johnston C, Skaggs D, Flynn J, Vitale M (2015) A new classification system to report complications in growing spine surgery: a multicenter consensus study. J Pediatr Orthop 35(8):798–803

    Article  PubMed  Google Scholar 

  48. Auerbach JD, Lenke LG, Bridwell KH, Sehn JK, Milby AH, Bumpass D et al (2012) Major complications and comparison between 3-column osteotomy techniques in 105 consecutive spinal deformity procedures. Spine 37(14):1198–1210

    Article  PubMed  Google Scholar 

  49. Thompson GH, Akbarnia BA, Kostial P, Poe-Kochert C, Armstrong DG, Roh J et al (2005) Comparison of single and dual growing rod techniques followed through definitive surgery: a preliminary study. Spine 30(18):2039–2044

    Article  PubMed  Google Scholar 

  50. Hosseini PAB, Emans J, Sponseller P, Pawelek J, Nguyen S, Sturm P, Growing Spine Study Group (2016) Construct levels to anchored levels ratio and rod diameter are associated with implant-related complications in traditional growing rods. Spine Deform 4(6):456–457

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Authors and Affiliations

  1. San Diego Spine Foundation, 6190 Cornerstone Ct, Ste 212, San Diego, CA, 92121, USA

    Pooria Hosseini, Areian Eghbali, Jeff Pawelek, Gregory M. Mundis & Behrooz A. Akbarnia

  2. Department of Orthopaedic Surgery, University of California, San Diego, San Diego, CA, USA

    Karen Heskett & Behrooz A. Akbarnia

  3. Scripps Clinic, 10666 N Torrey Pines Rd, La Jolla, CA, 92037, USA

    Gregory M. Mundis

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  1. Pooria Hosseini
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Contributions

Pooria Hosseini: substantial contributions to the conception and design of the work. The acquisition, analysis, or interpretation of data for the work. Drafting the work and revising it critically. Final approval of the version to be published. Areian Eghbali: the acquisition, analysis, or interpretation of data for the work. Drafting the work and revising it critically. Final approval of the version to be published. Jeff Pawelek: Substantial contributions to the design of the work. The acquisition, analysis, or interpretation of data for the work. Drafting the work and revising it critically. Final approval of the version to be published. Karen Heskett: The acquisition, analysis, or interpretation of data for the work. Final approval of the version to be published. Gregory M. Mundis: Substantial contributions to the conception and design of the work. The acquisition, analysis, or interpretation of data for the work. Drafting the work and revising it critically. Final approval of the version to be published. Behrooz A. Akbarnia: Substantial contributions to the conception and design of the work. The acquisition, analysis, or interpretation of data for the work. Drafting the work and revising it critically. Final approval of the version to be published.

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Correspondence to Behrooz A. Akbarnia.

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Conflict of interest

Behrooz A. Akbarnia: Nuvasive, K2M, DePuy Synthes (a), Nuvasive (d), Nuvasive (f), Nuvasive (g), GSF, SDSF, SRS, SOLAS (h). Gregory M. Mundis: Nuvasive (a, d, g), K2M (a,d), Allosource (d), ISSGF (g), SOLAS, SRS, SDSF, GSO (h). For the remaining authors none were declared. (a) Royalties (b) Speakers bureau/paid presentations (c) Paid employee (d) Paid consultant (e) Unpaid consultant (f) Stock or stock options (g) Research support from a company or supplier as a PI (h) Board member/committee appointments for a society (i) Other financial or material support.

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Both TGR and MCGR are FDA approved.

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Hosseini, P., Eghbali, A., Pawelek, J. et al. A high degree of variability exists in how “safety and efficacy” is defined and reported in growing rod surgery for early onset scoliosis: a systematic review. Spine Deform 8, 269–283 (2020). https://doi.org/10.1007/s43390-019-00004-4

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