Comparison of Two Methods of Subscapularis Management in Shoulder Arthroplasty: Tenotomy Versus Peel

Not Applicable

Completed

• Conditions: Subscapularis Injury

• Registration Number: NCT01404143
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel.

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.

Detailed Description

The primary research question is to determine the difference in subscapularis strength between two different methods of subscapularis mobilization in shoulder arthroplasty: intra-substance division of the tendon "tenotomy" versus direct detachment of the subscapularis tendon from its insertion on the lesser tuberosity "the peel". The primary outcome is strength as measured by a hand-held dynamometer in the belly-press position at one-year post operative. Secondary research questions include determination of the difference in disease specific quality of life between patients who undergo a subscapularis tenotomy versus subscapularis peel, as measured by the Western Ontario Osteoarthritis of the Shoulder Index (WOOS), Constant score and the ASES score at one year post-operatively. Finally, the healing rate of the subscapularis, as measured by ultrasound at 1 year post-operative will be determined.

Study Timeline

• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-27
• Study Start: 2011-08
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-14
• Last Update Posted: 2021-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel	12 months	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?

Secondary Outcome Measures

Name	Time	Method
Quality of life as measured by WORC, ASES and Constant	12 months	1. What is the difference in disease specific quality of life between patients who undergo a subscapularis tenotomy versus peel, as measured by the Western Ontario Osteoarthritis of the Shoulder Index (WOOS) at one year post-operatively in patients who undergo shoulder arthroplasty?; 2. What is the difference in outcome as measured by the Constant score and the ASES score, at one year post operatively?; 3. What are the healing rates, as measured by ultrasound at 1 year post-operative?

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada