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

Ottawa Hospital Research Institute

Status: Completed

Conditions: Subscapularis Injury

Treatments: Procedure: Subscapularis Tenotomy; Procedure: subscapularis peel

Study type: Interventional

Funder types: Other

Identifiers

NCT01404143

2011-352

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Subscapularis Tenotomy

Active Comparator group

Description:

This treatment group will undergo a technique that involves division of the tendon to gain access to the shoulder. After the deltopectoral approach is completed, the subscapularis tendon will be tenotomized one centimeter medial to its insertion on the lesser tuberosity.

Treatment:

Procedure: Subscapularis Tenotomy

Subscapularis Peel

Experimental group

Description:

This treatment group will use a technique that involves elevation of the tendon off the bone in order to gain access to the shoulder.The subscapularis will be elevated from the lesser tuberosity.

Treatment:

Procedure: subscapularis peel