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

NCT01404143 | Completed

• 1 other identifier: 2011-352
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Subscapularis Injury

Outcome Measures

Primary Outcomes (1)

• What is the difference in subscapularis strength between two different methods of subscapularis mobilization: incision of the tendon (tenotomy) versus peel

  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?

  12 months

Secondary Outcomes (1)

• Quality of life as measured by WORC, ASES and Constant

  12 months

Study Arms (2)

Subscapularis Tenotomy

ACTIVE COMPARATOR

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.

Procedure: Subscapularis Tenotomy

Subscapularis Peel

EXPERIMENTAL

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.

Procedure: subscapularis peel

Interventions

Subscapularis Tenotomy PROCEDURE

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).

Subscapularis Tenotomy

subscapularis peel PROCEDURE

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.

Subscapularis Peel

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• St. Joseph's Health Care London: collaborator
• Unity Health Toronto: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Study Officials

• Peter Lapner, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 27, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 17, 2021

Record last verified: 2021-05

Locations

CA (1)