Anterior Shoulder Instability Treated with a Semitendinosus Subscapular Sling Procedure

N/AActive Not RecruitingNCT03424421

Helse Møre og Romsdal HF15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anterior Shoulder Dislocation Joint Instability

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Explore to what extent the subscapular sling procedure is successful in preventing recurrent shoulder dislocations

Time frame: 2 , 5 and 10 years follow up.

Secondary Outcomes

Changes in the Western Ontario Shoulder Instability index (WOSI) score

Changes in the WOSI score, comparing results preoperatively

Time frame: 2, 5 and 10 years follow up.

Changes in the range of motions

Range of motions, comparing postoperative results with preoperative measurements in the operated shoulder