Overview

This trial is active, not recruiting.

Condition subscapularis injury
Treatments subscapularis tenotomy, subscapularis peel
Sponsor Ottawa Hospital Research Institute
Collaborator St. Joseph's Health Care London
Start date August 2011
End date April 2016
Trial size 80 participants
Trial identifier NCT01404143, 2011-352

Summary

What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel, as measured by a hand-held dynamometer in the belly-press position at one year post operative? It is the investigators' hypothesis that a peel of the subscapularis will result in greater strength, a higher healing rate, and a greater improvement in shoulder function and quality of life following shoulder replacement.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
subscapularis tenotomy
After the deltopectoral approach is completed, the subscapularis tendon will be tenotomized one centimeter medial to its insertion on the lesser tuberosity. The tendon will be tagged for later repair. Repair will take place with a combination of transosseous sutures (3) placed in a mattress configuration through the area of exposed lesser tuberosity. In addition, a soft tissue tendon to tendon repair will be carried out using figure-8 stitches using #2 (heavy) non-absorbable suture (Ticron).
(Experimental)
subscapularis peel
The subscapularis will be elevated from the lesser tuberosity. The tendon will be tagged with stay sutures for later reattachment (3 sutures in mattress configuration). Reapproximation will take place with three non-absorbable mattress sutures placed in a trans-osseous fashion through the bicipital groove, exiting the greater tuberosity and tied over a 4-hole mini-fragment plate.

Primary Outcomes

Measure
What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel
time frame: 12 months

Secondary Outcomes

Measure
Quality of life as measured by WORC, ASES and Constant
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: - Age 18 years or older - Imaging, and intra-operative findings confirming advanced humeral head cartilage loss, and/glenoid cartilage loss. - Ability to understand and adhere to rehab protocols and testing procedure - Persistent pain and functional disability for at least 6 months and failure of 6 months of conservative treatment - surgical arthroplasty patients Exclusion Criteria: - Active joint of systemic infection - Significant muscle paralysis - Rotator cuff tear arthropathy - Pregnancy - Charcot's arthropathy - Major medical illness ( life expectancy less then 1 year or unacceptably high operative risk) - Patients unable to provide informed consent due to language barrier or mental status - Unable to speak or read English/French - Psychiatric illness that precludes informed consent - Patients unwilling to be followed for the duration of the study.

Additional Information

Official title Comparison of Two Methods of Subscapularis Management in Shoulder Arthroplasty: Tenotomy Versus Peel: A Multicenter, Randomized Controlled
Principal investigator Peter Lapner, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Ottawa Hospital Research Institute.