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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03424421
Other study ID # 2017/1292
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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.
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