Clinical trial NCT03424421: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anterior Shoulder Dislocation
Joint Instability
Keywords: Shoulder Joint
Orthopedics
Arthroscopy
Lead sponsor: Helse Møre og Romsdal HF
Sponsor class: OTHER_GOV
Collaborators: name: Norwegian University of Science and Technology
name: Oslo University Hospital
First posted: 2018-02-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pilot study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The recurrence rate of shoulder dislocation after the subscapular sling
timeFrame: 2 , 5 and 10 years follow up.
Secondary outcomes:
measure: Changes in the Western Ontario Shoulder Instability index (WOSI) score
timeFrame: 2, 5 and 10 years follow up.
measure: Changes in the range of motions
timeFrame: 2, 5 and 10 years follow up.
Other outcomes:
Locations:
city: Ålesund
country: Norway
facility: Aalesund Hospital Møre and Romsdal Hospital Trust
Study officials:
affiliation: Norwegian University of Science and Technology
name: Jon Olav Drogset, MD PhD prof
role: STUDY_DIRECTOR
References:
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.