Anterior Shoulder Instability Treated with a Semitendinos... | NCT03424421

Studies
Anterior Shoulder Instability Treated with a Semitendinosus Subscapular Sling Procedure

NCT03424421

Sponsor

Helse Møre og Romsdal HF

Status

Active, not recruiting

Last Update Posted

Mar 14, 2025Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Anterior Shoulder Dislocation
Joint Instability

Interventions

subscapular sling

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2017Actual

Primary Completion Date

Feb 5, 2024Actual

Completion Date

Aug 30, 2032Estimated

First Submitted Date

Jan 26, 2018

First Submission Date that Met QC Criteria

Jan 31, 2018

First Posted Date

Feb 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2025

Last Update Posted Date

Mar 14, 2025Actual

Name	Class
Norwegian University of Science and Technology	OTHER
Oslo University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
subscapular sling	Experimental	semitendinosus subscapular sling procedure	Procedure: subscapular sling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
subscapular sling	Procedure	semitendinosus subscapular sling procedure	subscapular sling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Changes in the Western Ontario Shoulder Instability index (WOSI) score	Changes in the WOSI score, comparing results preoperatively	2, 5 and 10 years follow up.
Changes in the range of motions

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jon Olav Drogset, MD PhD prof	Norwegian University of Science and Technology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aalesund Hospital Møre and Romsdal Hospital Trust		Ålesund	Ålesund	6013	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26914880	Background	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.

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases