Clinical Trial

Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure

Active, Not Recruiting
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Summary
The arthroscopic subscapular sling procedure is a new technique for shoulder stabilization, which has been developed in human cadaveric studies by Klungsøyr et al, but has yet to be tested clinically. The procedure stabilizes the shoulder by using a semitendinosus graft that makes a new labrum and a sling around the subscapular tendon. Extensive biomechanical robotic testing of the procedure shows significant less translation and thus better stability of the humeral head with the sling compared to a normal Bankart repair. The investigators consider the biomechanical results after robotic testing sufficient to advocate a planned pilot study in humans. In this pilot study the clinical and radiological results of the sling will be investigated in a small number of cases. The safety of the subscapular sling procedure will be assessed. This studies results are expected to be a further step towards implementation of the sling procedure as a surgical option for shoulder instability.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2018-01-31; most recent amendment 2025-03-12.
Status change: Enrolling by Invitation → Active, Not Recruiting 2023-08-22
Trial Details
NCT Number NCT03424421
Lead Sponsor Helse Møre og Romsdal HF
Collaborators: Norwegian University of Science and Technology, Oslo University Hospital
Conditions Anterior Shoulder Dislocation, Joint Instability
Enrollment 15 participants
Start Date 2017-12-20
Primary Completion 2024-02-05 (estimated)
Study Completion 2032-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-11