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Active Not RecruitingNCT03424421

Anterior Shoulder Instability Treated with a Semitendinosus Subscapular Sling Procedure

Anterior Shoulder Instability Treated with a Semitendinosus Subscapular Sling Procedure. Pilot Study, a New Surgical Procedure

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Helse Møre og Romsdal HF · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREsubscapular slingsemitendinosus subscapular sling procedure

Timeline

Start date
2017-12-20
Primary completion
2024-02-05
Completion
2032-08-30
First posted
2018-02-07
Last updated
2025-03-14

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT03424421. Inclusion in this directory is not an endorsement.

Anterior Shoulder Instability Treated with a Semitendinosus Subscapular Sling Procedure (NCT03424421) · Clinical Trials Directory