Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03424421

Enrollment

Registered

2018-02-07

Start date

2017-12-20

Completion date

2032-08-30

Last updated

2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Shoulder Dislocation, Joint Instability

Keywords

Shoulder Joint, Orthopedics, Arthroscopy

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.

Interventions

PROCEDUREsubscapular sling

semitendinosus subscapular sling procedure

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

pilot study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Norway

Contacts

STUDY_DIRECTORJon Olav Drogset, MD PhD prof

Norwegian University of Science and Technology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026