Clinical trial NCT01404143: Comparison of Two Methods of Subscapularis Management in Shoulder Arthroplasty: Tenotomy Versus Peel
Official title: Comparison of Two Methods of Subscapularis Management in Shoulder Arthroplasty: Tenotomy Versus Peel: A Multicenter, Randomized Controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subscapularis Injury
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: St. Joseph's Health Care London
name: Unity Health Toronto
First posted: 2011-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life as measured by WORC, ASES and Constant
timeFrame: 12 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Peter Lapner, MD
role: PRINCIPAL_INVESTIGATOR
References: