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NCT Number: NCT03424421

Anterior Shoulder Instability Treated with a Semitendinosus Subscapular Sling Procedure

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.

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Key information

Conditions

Anterior Shoulder Dislocation Joint Diseases Joint Instability Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalesund Hospital Møre and Romsdal Hospital Trust

Ålesund, 6013, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

subscapular sling

Procedure

semitendinosus subscapular sling procedure

Primary outcomes

  1. The recurrence rate of shoulder dislocation after the subscapular sling

    Time frame: 2 , 5 and 10 years follow up.

    Explore to what extent the subscapular sling procedure is successful in preventing recurrent shoulder dislocations

Secondary outcomes

  1. Changes in the Western Ontario Shoulder Instability index (WOSI) score

    Time frame: 2, 5 and 10 years follow up.

    Changes in the WOSI score, comparing results preoperatively

  2. Changes in the range of motions

    Time frame: 2, 5 and 10 years follow up.

    Range of motions, comparing postoperative results with preoperative measurements in the operated shoulder

Sponsors and collaborators

Lead sponsor

Helse Møre og Romsdal HF

Other Gov

Collaborators

  • Norwegian University of Science and Technology
  • Oslo University Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2024
Study completion
2032
First posted
Feb 7, 2018
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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