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Spine Growth Modulation in Early Adolescent Idiopathic Scoliosis: Two-Year Results of Prospective US FDA IDE Pilot Clinical Safety Study of Titanium Clip-Screw Implant

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Abstract

Study Design

Prospective pilot clinical safety study of novel treatment, consecutive case series from first human use in patients with early adolescent idiopathic scoliosis (AIS).

Objective

The primary purpose was to determine the initial safety of a titanium clip-screw implant system for spine growth modulation. The secondary aim was to document curvatures to 2 years postoperatively.

Summary of Background Data

Spinal growth modulation was documented in preclinical studies. A prospective pilot clinical safety study was then performed under a Food and Drug Administration (FDA) Investigational Device Exemption (IDE) (www.clinicaltrials.gov Identifier: NCT01465295).

Methods

Six subjects with early AIS underwent thoracoscopic placement of titanium clip-screw devices. Eligibility criteria included only patients at high risk for progression to 50°: single major thoracic curve 25°–40°, age ⩾10 years, skeletally immature (Risser 0 plus open triradiate cartilages), and if female, premenarchal. Adverse events (AEs), clinical outcomes, and radiographic measures were documented using Good Clinical Practices.

Results

Six consecutive subjects were enrolled, three females and three males aged 12.1 years (±1.7). AEs included one that was device related—mild device migration at 18 months in the most rapidly progressive curve. Procedure-related AEs were mostly pulmonary. A chylous effusion that met the clinical protocol definition of a serious AE resolved after minimally invasive interventions. Major thoracic curves were 34° (±3°) preoperatively and 38° (±18°) at two years (intrasubject change, 4° ± 18°). At 24 months, curves in 3 patients were >45° and 3 were <40°.

Conclusions

A spine growth modulation system undergoing study under an FDA IDE was determined to be safe. Variability in curve response to the implant was high, ranging from progression to correction. Investigational approval was granted by the US FDA for the next cohort of 30 subjects.

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Author information

Authors and Affiliations

  1. Cincinnati Children’s Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH, 45229, USA

    Eric J. Wall MD, Viral V. Jain MD, Donita I. Bylski-Austrow PhD, Paul J. Samuels MD, Sean J. Barnett MD & Alvin H. Crawford MD

  2. Orthopaedics, University of Cincinnati, 231 Albert Sabin Way, Cincinnati, OH, 45267, USA

    Eric J. Wall MD, Viral V. Jain MD, Donita I. Bylski-Austrow PhD & Alvin H. Crawford MD

  3. SpineForm, LLC, 4480 Lake Forest Drive, Suite 414, Cincinnati, OH, 45242-3754, USA

    Joseph E. Reynolds MBA

  4. Orthopaedics, Rainbow Babies and Children’s Hospital, Cleveland, OH, 44106, USA

    George H. Thompson MD

Authors
  1. Eric J. Wall MD
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Corresponding author

Correspondence to Donita I. Bylski-Austrow PhD.

Additional information

Author disclosures

EJW (grants from FDA and the Ohio Department of Development; personal fees, nonfinancial support, and other from SpineForm LLC, during the conduct of the study; and patents 8021403, 6746450, 7481830, and 6,746,450 licensed to SpineForm LLC); JER (grants from FDA and the Ohio Department of Development; personal fees, nonfinancial support, and other from SpineForm LLC, during the conduct of the study; and has patents 8021403, 8062294, 6746450, and 7481830 issued); VVJ (reports other from SpineForm LLC; other from Medtronic, outside the submitted work); DIB-A (grants and nonfinancial support from SpineForm LLC, grants from FDA, via SpineForm LLC, and from the Ohio Department of Development, during the conduct of the study; and patents 6,746,450, 7,481,830, and 8,021,403 licensed to SpineForm LLC); GHT (personal fees from Wolters Kluwer, OrthoPediatrics, Shriner’s Hospital for Children, Broadwater, Medtronic, and Stryker; other from SpineForm; and other from SICOT, outside the submitted work); PJS (grants from FDA and the Ohio Department of Development; personal fees from SpineForm LLC, during the conduct of the study); SJB (other from SpineForm LLC, during the conduct of the study; other from Kaleidoscope, Inc, and Ascend Innovations, outside the submitted work); AHC (nonfinancial support from SpineForm LLC, during the conduct of the study; and a patent 9,072,554 licensed to SpineForm LLC).

Grant funding to support this study was awarded to sponsor SpineForm LLC by the State of Ohio, Ohio Third Frontier (2010-13) and USA FDA R01 1-R01 FD0004414-01 (2012-13).

Device Status Statement: The devices that are the subject of this manuscript are being evaluated as part of an ongoing FDA-approved investigational protocol (IDE) for the intended use of guided spinal growth treatment of progressive idiopathic scoliosis (IS). The test article is intended for anterior-lateral fixation across the growth plates from T3 to L1 with placement through video-assisted thoracoscopic surgery.

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Wall, E.J., Reynolds, J.E., Jain, V.V. et al. Spine Growth Modulation in Early Adolescent Idiopathic Scoliosis: Two-Year Results of Prospective US FDA IDE Pilot Clinical Safety Study of Titanium Clip-Screw Implant. Spine Deform 5, 314–324 (2017). https://doi.org/10.1016/j.jspd.2017.02.004

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  • DOI: https://doi.org/10.1016/j.jspd.2017.02.004

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