Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure

Sponsor

Helse Møre og Romsdal HF (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03424421

Collaborator

Norwegian University of Science and Technology (Other), Oslo University Hospital (Other)

Enrollment

Location

Arm

64.3

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anterior Shoulder Dislocation Joint Instability	Procedure: subscapular sling	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

pilot studypilot study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 20, 2017

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: subscapular sling semitendinosus subscapular sling procedure	Procedure: subscapular sling semitendinosus subscapular sling procedure

Arm

Intervention/Treatment

Experimental: subscapular sling

semitendinosus subscapular sling procedure

Procedure: subscapular sling

semitendinosus subscapular sling procedure

Outcome Measures

Primary Outcome Measures

The recurrence rate of shoulder dislocation after the subscapular sling [2 years follow up.]
Explore to what extent the subscapular sling procedure is successful in preventing recurrent shoulder dislocations

Secondary Outcome Measures

Changes in the Western Ontario Shoulder Instability index (WOSI) score [2 years follow up.]
Changes in the WOSI score, comparing results preoperatively
Changes in the range of motions [2 years follow up.]
Range of motions, comparing postoperative results with preoperative measurements in the operated shoulder

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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