Trials / Active Not Recruiting
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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | subscapular sling | semitendinosus 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.