Landscape of interventional clinical trials for glenohumeral instability

Background

This study reviews interventional clinical trials to evaluate the efficacy and evolution of current therapeutic strategies for shoulder instability.

Methods

ClinicalTrials.gov was queried using key search terms for interventional clinical trials targeting shoulder instability. Data extracted included phase, status, duration, country, population size, age groups, study design, enrollment models, interventions, and outcomes. Publication rate was calculated by the ratio of published articles to total number of included trials.

Results

Forty-five interventional trials investigating shoulder instability were included. Most trials did not have a defined phase. Most trials (>90 %) began post-2010 with an average duration of 37 months. Europe/UK/Russia led in trial numbers (55.6 %). Primary endpoints focused on shoulder function and mobility, with the Western-Ontario-Shoulder-Instability-Index being the most common outcome measure. Interventions included surgical procedures (46.7 %), physical therapy (37.8 %), behavioral therapy (4.4 %), and other modalities (11.1 %). Nine trials produced 14 publications, resulting in a publication rate of 25.9 %. Published results varied, including comparisons of treatment efficacy, such as heavy versus light strengthening programs, and outcomes for surgical and non-surgical interventions.

Conclusion

Interventional trials on shoulder instability are limited, mostly originating from Europe and North America. Low publication rates and lack of blinding highlight areas for improvement. Publishing results is essential for continuous development and outcome improvement.