Anterior Shoulder Instability Treated with a Semitendinosus Subscapular Sling Procedure

NCT03424421 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-03-14

No results posted yet for this 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.

Conditions

  • Anterior Shoulder Dislocation
  • Joint Instability

Interventions

PROCEDURE

subscapular sling

semitendinosus subscapular sling procedure

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    collaborator OTHER
  • Oslo University Hospital

    collaborator OTHER
  • Helse Møre og Romsdal HF

    lead OTHER_GOV

Principal Investigators

  • Jon Olav Drogset, MD PhD prof · Norwegian University of Science and Technology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-20
Primary Completion
2024-02-05
Completion
2032-08-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03424421 on ClinicalTrials.gov