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Active, not recruitingNCT03424421Updated Aug 11, 2026

Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure

An interventional study of subscapular sling in Anterior Shoulder Dislocation and Joint Instability, sponsored by Helse Møre og Romsdal HF. Active, not recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Helse Møre og Romsdal HF · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Anterior Shoulder Dislocation
  • Joint Instability

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Keywords

  • Shoulder Joint
  • Orthopedics
  • Arthroscopy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    subscapular sling

    semitendinosus subscapular sling procedure

    Procedure: subscapular sling

Interventions

  • Proceduresubscapular sling

    semitendinosus subscapular sling procedure

05

What researchers measure

Primary outcomes

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

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

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

Secondary outcomes

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

    Changes in the WOSI score, comparing results preoperatively

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

  2. Changes in the range of motions

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

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

06

Study locations

1 site
  • Aalesund Hospital Møre and Romsdal Hospital Trust
    Ålesund, Ålesund 6013, Norway
07

References and documents

Publications

  • Klungsoyr PJ, Guldal F, Vagstad T, Klungsoyr JA. A new subscapular sling operation to stabilize the shoulder. A cadaver study. J Exp Orthop. 2015 Dec;2(1):12. doi: 10.1186/s40634-015-0028-y. Epub 2015 Jun 2. PubMed 26914880 ↗
08

Registry details

Key details

Study ID
NCT03424421
Lead sponsor
Helse Møre og Romsdal HF
Collaborators
Norwegian University of Science and Technology, Oslo University Hospital
Responsible party
Sponsor
First posted
Feb 7, 2018
Start date
Dec 20, 2017
Primary completion
Feb 5, 2024
Completion
Aug 30, 2032 (estimated)
Last update
Aug 11, 2026

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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