NCT03424421

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
77mo left

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Dec 2017Aug 2032

Study Start

First participant enrolled

December 20, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 26, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
8.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2032

Expected
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

6.1 years

First QC Date

January 26, 2018

Last Update Submit

March 12, 2025

Conditions

Anterior Shoulder DislocationJoint Instability

Keywords

Shoulder JointOrthopedicsArthroscopy

Outcome Measures

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

    2 , 5 and 10 years follow up.

Secondary Outcomes (2)

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

    2, 5 and 10 years follow up.

  • Changes in the range of motions

    2, 5 and 10 years follow up.

Study Arms (1)

subscapular sling

EXPERIMENTAL

semitendinosus subscapular sling procedure

Procedure: subscapular sling

Interventions

subscapular slingPROCEDURE

semitendinosus subscapular sling procedure

subscapular sling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalesund Hospital Møre and Romsdal Hospital Trust

Ålesund, Ålesund, 6013, Norway

Location

Related Publications (1)

  • 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.

    PMID: 26914880BACKGROUND

MeSH Terms

Conditions

Joint Instability

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Jon Olav Drogset, MD PhD prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: pilot study
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 7, 2018

Study Start

December 20, 2017

Primary Completion

February 5, 2024

Study Completion (Estimated)

August 30, 2032

Last Updated

March 14, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)