Anterior Shoulder Instability Treated with a Semitendinosus Subscapular Sling Procedure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-20

Study Completion Date

2032-08-30

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.

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Detailed Description

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Conditions

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Anterior Shoulder Dislocation Joint Instability

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

pilot study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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subscapular sling

semitendinosus subscapular sling procedure

Group Type EXPERIMENTAL

subscapular sling

Intervention Type PROCEDURE

semitendinosus subscapular sling procedure

Interventions

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subscapular sling

semitendinosus subscapular sling procedure

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No