Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure

Study Overview
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Brief Summary
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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.

Official Title
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Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure. Pilot Study, a New Surgical Procedure

Conditions
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Anterior Shoulder Dislocation, Joint Instability

Intervention / Treatment
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* Procedure: subscapular sling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: subscapular sling<br>semitendinosus subscapular sling procedure | Procedure: subscapular sling<br>* semitendinosus subscapular sling procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The recurrence rate of shoulder dislocation after the subscapular sling | Explore to what extent the subscapular sling procedure is successful in preventing recurrent shoulder dislocations | 2 years follow up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Western Ontario Shoulder Instability index (WOSI) score | Changes in the WOSI score, comparing results preoperatively | 2 years follow up. | 
| Changes in the range of motions | Range of motions, comparing postoperative results with preoperative measurements in the operated shoulder | 2 years follow up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder Joint, Orthopedics, Arthroscopy