- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03424421
Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure
February 5, 2024 updated by: Helse Møre og Romsdal HF
Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure. Pilot Study, a New Surgical 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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ålesund, Norway, 6013
- Aalesund Hospital Møre and Romsdal Hospital Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: subscapular sling
semitendinosus subscapular sling procedure
|
semitendinosus subscapular sling procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 , 5 and 10 years follow up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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, 5 and 10 years follow up.
|
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
|
2, 5 and 10 years follow up.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jon Olav Drogset, MD PhD prof, Norwegian University of Science and Technology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2017
Primary Completion (Actual)
February 5, 2024
Study Completion (Estimated)
August 30, 2032
Study Registration Dates
First Submitted
January 26, 2018
First Submitted That Met QC Criteria
January 31, 2018
First Posted (Actual)
February 7, 2018
Study Record Updates
Last Update Posted (Estimated)
February 7, 2024
Last Update Submitted That Met QC Criteria
February 5, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/1292
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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