Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure

Joint Instability Clinical Trial

Official title:

Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure. Pilot Study, a New Surgical Procedure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03424421
• Other study ID #: 2017/1292
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 20, 2017
• Est. completion date: August 30, 2032

Study information

• Verified date: February 2024
• Source: Helse Møre og Romsdal HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: August 30, 2032
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Shoulder Dislocation
• Joint Instability
• Shoulder Dislocation

Intervention

Procedure:
• subscapular sling
semitendinosus subscapular sling procedure

Locations

Country	Name	City	State
Norway	Aalesund Hospital Møre and Romsdal Hospital Trust	Ålesund

Sponsors (3)

Lead Sponsor	Collaborator
Helse Møre og Romsdal HF	Norwegian University of Science and Technology, Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Changes in the range of motions	Range of motions, comparing postoperative results with preoperative measurements in the operated shoulder	2, 5 and 10 years follow up.