Anterior Shoulder Instability Treated with a Semitendinosus Subscapular Sling Procedure. Pilot Study, a New Surgical Procedure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anterior Shoulder Dislocation
- Sponsor
- Helse Møre og Romsdal HF
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- The recurrence rate of shoulder dislocation after the subscapular sling
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical anterior instability of the shoulder and/or previous failed Bankart repair or arthroscopic findings concluding with too weak anterior structures to perform capsulolabral or labrum repair
- •Be able to understand oral and written Norwegian /English
Exclusion Criteria
- •Cuff injury or previous cuff repair
- •Surgical fracture treatment of the glenoid or humeral head
- •Other instability procedures in the shoulder except Bankart repair and anterior capsular plications
- •Previous infections in the shoulder
- •MRI detectable fatty infiltration of the subscapularis or partial/total tendon rupture
- •Severe glenohumeral arthrosis
- •Multidirectional or posterior instability
- •Not able to comply fully with the protocol due to psychosocial and physical conditions
Outcomes
Primary Outcomes
The recurrence rate of shoulder dislocation after the subscapular sling
Time Frame: 2 , 5 and 10 years follow up.
Explore to what extent the subscapular sling procedure is successful in preventing recurrent shoulder dislocations
Secondary Outcomes
- Changes in the Western Ontario Shoulder Instability index (WOSI) score(2, 5 and 10 years follow up.)
- Changes in the range of motions(2, 5 and 10 years follow up.)