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Clinical Trials in Norway / NCT03424421
Active, not recruiting Not applicable

Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure

NCT03424421 · tracked via the Priya Life Science Norway tracker
Phase
Not applicable
Started
2017-12-20
Last updated
2026-08-11

Condition(s) studied

Anterior Shoulder DislocationJoint Instability

Investigational drug(s) / intervention(s)

subscapular sling

subscapular sling: semitendinosus subscapular sling procedure

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Aalesund Hospital Møre and Romsdal Hospital Trust Ålesund Ålesund

More Helse Møre og Romsdal HF trials in Norway

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03424421 on ClinicalTrials.gov ↗ ← All trials in Norway