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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
St. Joseph's Health Care London
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01404143
First received: July 26, 2011
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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 Intervention
Subscapularis Injury
Procedure: Subscapularis Tenotomy
Procedure: subscapularis peel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Methods of Subscapularis Management in Shoulder Arthroplasty: Tenotomy Versus Peel: A Multicenter, Randomized Controlled

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Quality of life as measured by WORC, ASES and Constant [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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?


Estimated Enrollment: 80
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01404143     History of Changes
Other Study ID Numbers: 2011-352
Study First Received: July 26, 2011
Last Updated: September 8, 2014
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on October 23, 2014