Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure

Not Applicable

Active, not recruiting

• Conditions: Anterior Shoulder Dislocation; Joint Instability
• Interventions: Procedure: subscapular sling

• Registration Number: NCT03424421
• Lead Sponsor: Helse Møre og Romsdal HF

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2017-12-20
• Study First Submitted: 2018-01-26
• Study First Submitted QC: 2018-01-31
• Study First Posted: 2018-02-07
• Status Verified: 2024-02
• Primary Completion: 2024-02-05
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Study Completion: 2032-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
subscapular sling	subscapular sling	semitendinosus subscapular sling procedure

Primary Outcome Measures

Name	Time	Method
The recurrence rate of shoulder dislocation after the subscapular sling	2 , 5 and 10 years follow up.	Explore to what extent the subscapular sling procedure is successful in preventing recurrent shoulder dislocations

Secondary Outcome Measures

Name	Time	Method
Changes in the Western Ontario Shoulder Instability index (WOSI) score	2, 5 and 10 years follow up.	Changes in the WOSI score, comparing results preoperatively
Changes in the range of motions	2, 5 and 10 years follow up.	Range of motions, comparing postoperative results with preoperative measurements in the operated shoulder

Trial Locations

Locations (1)

Aalesund Hospital Møre and Romsdal Hospital Trust; 🇳🇴 Ålesund, Norway