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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
Sponsor:
Collaborators:
St. Joseph's Health Care London
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
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, 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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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?


Secondary Outcome Measures :
  1. Quality of life as measured by WORC, ASES and Constant [ Time Frame: 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?



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
St. Joseph's Health Care London
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Peter Lapner, MD The Ottawa Hospital

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01404143     History of Changes
Other Study ID Numbers: 2011-352
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided