Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure

Helse Møre og Romsdal HF

Status: Active, not recruiting

Conditions: Anterior Shoulder Dislocation; Joint Instability

Treatments: Procedure: subscapular sling

Study type: Interventional

Funder types: Other

Identifiers

NCT03424421

2017/1292

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

subscapular sling

Experimental group

Description:

semitendinosus subscapular sling procedure

Treatment:

Procedure: subscapular sling