Comparison of Two Methods of Subscapularis Management in Shoulder Arthroplasty: Tenotomy Versus Peel
This trial is active, not recruiting.
|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|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, outcomes assessor)|
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
Quality of life as measured by WORC, ASES and Constant
time frame: 12 months
Male or female participants from 18 years up to 90 years old.
- 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
- Active joint of systemic infection
- Significant muscle paralysis
- Rotator cuff tear arthropathy
- 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.
|Official title||Comparison of Two Methods of Subscapularis Management in Shoulder Arthroplasty: Tenotomy Versus Peel: A Multicenter, Randomized Controlled|
|Principal investigator||Peter Lapner, MD|
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