Comparison of Two Methods of Subscapularis Management in Shoulder Arthroplasty: Tenotomy Versus Peel
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|ClinicalTrials.gov Identifier: NCT01404143|
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : March 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Subscapularis Injury||Procedure: Subscapularis Tenotomy Procedure: subscapularis peel||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Comparison of Two Methods of Subscapularis Management in Shoulder Arthroplasty: Tenotomy Versus Peel: A Multicenter, Randomized Controlled|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
|Active Comparator: Subscapularis Tenotomy||
Procedure: 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||
Procedure: 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.
- 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 ]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?
- Quality of life as measured by WORC, ASES and Constant [ Time Frame: 12 months ]
- 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?
- What is the difference in outcome as measured by the Constant score and the ASES score, at one year post operatively?
- What are the healing rates, as measured by ultrasound at 1 year post-operative?
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404143
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1H 8L6|
|Principal Investigator:||Peter Lapner, MD||The Ottawa Hospital|