Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure
Primary Purpose
Anterior Shoulder Dislocation, Joint Instability
Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
subscapular sling
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Shoulder Dislocation focused on measuring Shoulder Joint, Orthopedics, Arthroscopy
Eligibility Criteria
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
Sites / Locations
- Aalesund Hospital Møre and Romsdal Hospital Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
subscapular sling
Arm Description
semitendinosus subscapular sling procedure
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Changes in the Western Ontario Shoulder Instability index (WOSI) score
Changes in the WOSI score, comparing results preoperatively
Changes in the range of motions
Range of motions, comparing postoperative results with preoperative measurements in the operated shoulder
Full Information
NCT ID
NCT03424421
First Posted
January 26, 2018
Last Updated
August 22, 2023
Sponsor
Helse Møre og Romsdal HF
Collaborators
Norwegian University of Science and Technology, Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03424421
Brief Title
Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure
Official Title
Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure. Pilot Study, a New Surgical Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Møre og Romsdal HF
Collaborators
Norwegian University of Science and Technology, Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Shoulder Dislocation, Joint Instability
Keywords
Shoulder Joint, Orthopedics, Arthroscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
subscapular sling
Arm Type
Experimental
Arm Description
semitendinosus subscapular sling procedure
Intervention Type
Procedure
Intervention Name(s)
subscapular sling
Intervention Description
semitendinosus subscapular sling procedure
Primary Outcome Measure Information:
Title
The recurrence rate of shoulder dislocation after the subscapular sling
Description
Explore to what extent the subscapular sling procedure is successful in preventing recurrent shoulder dislocations
Time Frame
2 years follow up.
Secondary Outcome Measure Information:
Title
Changes in the Western Ontario Shoulder Instability index (WOSI) score
Description
Changes in the WOSI score, comparing results preoperatively
Time Frame
2 years follow up.
Title
Changes in the range of motions
Description
Range of motions, comparing postoperative results with preoperative measurements in the operated shoulder
Time Frame
2 years follow up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Olav Drogset, MD PhD prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Aalesund Hospital Møre and Romsdal Hospital Trust
City
Ålesund
ZIP/Postal Code
6013
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
26914880
Citation
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.
Results Reference
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Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure
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