VTI InterFuse® S vs. InterFuse® T for the treatment of scoliosis and degenerative disc disease: protocol for a multicenter post-market study

Background and objectives: VTI InterFuse® S and InterFuse® T are the interbody fusion devices used in spinal fusion procedures to relieve the pain of patients with scoliosis and degenerative disc disease through maintaining foraminal height and decompression. The aim of this study is to investigate the therapeutic effects of the VTI InterFuse® S and InterFuse® T on scoliosis and degenerative disc disease.Design: A prospective, two-arm, multicenter, post-market trial.Methods: A total of 200 eligible patients (18-19 years old) with scoliosis and/or degenerative disc disease and a planned fusion of at least 5 levels were recruited from 10 clinical sites. The patients will be assigned to receive T interbody fusion treatment with the InterFuse® S or InterFuse® interbody fusion devices. Outcome measures: The following outcome measures will be observed during 24-month follow-up: interbody fusion assessed by CT scan (primary outcome measure), and Visual Analog Scale and Oswestry Disability Index, and the Scoliosis Research Society Outcomes Instrument scores (secondary outcome measures).Discussion: This study will provide direct evidence for the intelligent use of VTI InterFuse® S and InterFuse® T interbody fusion devices in the treatment of scoliosis and/or degenerative disc disease.Ethics and dissemination: The study will receive approval from the institutional review board at each site and will be conducted in accordance with the ethical principles of the Declaration of Helsinki. Results will be presented at national and international meetings and submitted for publication to peer-reviewed journals.Trial registration: ClinicalTrials.gov identifier: NCT02659722 on January 15 th , 2016.DOI: 10.4103/2542-4157.213687How to cite this article:Lavelle WF, Tallarico R, Felt JC. VTI InterFuse® S vs. InterFuse® T for the treatment of scoliosis and degenerative disc disease: protocol for a multicenter post-market study. Clin Trials Orthop Disord 2017;2:104-12