• World Neurosurg · Jun 2023

    Characterizing the Current Clinical Trial Landscape in Spinal Deformity: A Retrospective Analysis of Trends in the Clinicaltrials.gov Registry.

    • Jeffrey W Chen, Michael Martini, Zach Pennington, Nikita Lakomkin, Anthony L Mikula, Arjun S Sebastian, Brett A Freedman, Mohamad Bydon, Benjamin D Elder, and Jeremy L Fogelson.
    • Vanderbilt University, School of Medicine, Nashville, Tennessee, USA. Electronic address: jeffrey.w.chen@vanderbilt.edu.
    • World Neurosurg. 2023 Jun 1; 174: e92e102e92-e102.

    BackgroundThe management of adult spinal deformity (ASD) relies upon retrospective data, but there have been calls for prospective trials to improve the evidentiary base. This study sought to define the state of the spinal deformity clinical trials and highlight trends to guide future research.MethodsThe ClinicalTrials.gov database was queried for all ASD trials initiated since 2008. ASD was defined as adults (>18 years) and defined by the trial. All identified trials were categorized by enrollment status, study design, funding source, start and completion dates, country, outcomes examined, among many other study characteristics.ResultsSixty trials were included, of which 33(55.0%) started within the past 5 years of the query date. Most trials were sponsored by academic centers (60.0%) followed by industry (48.3%). Notably, 16 (27%) trials had multiple funding sources, all included collaboration with an industry entity. Only one trial had funding from a government agency. There were 30 (50%) interventional and 30 (50%) observational studies. The average time to completion was 50.8 ± 49.1 months. A total of 23 (38.3%) studies investigated a new procedural innovation, while 17 (28.3%) studies examined the safety or efficacy of a device. Study publications were associated with 17 (28.3%) trials in the registry.ConclusionsThe number of trials has increased significantly over the past 5 years, with the bulk of trials being funded by academic centers and industry and a notably lack by government agencies. Most trials focused on device or procedural investigation. Despite growing interest in ASD clinical trials, there remain many points for improvement in the current evidentiary base.Copyright © 2023 Elsevier Inc. All rights reserved.

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