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

NCT ID: NCT01404143

Last Updated: 2021-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2017-09-30

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.

Detailed 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.

Conditions

Subscapularis Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Subscapularis Tenotomy

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.

Group Type: ACTIVE_COMPARATOR

Subscapularis Tenotomy

Intervention Type: 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 Peel

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.

Group Type: EXPERIMENTAL

subscapularis peel

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Joseph's Health Care London

OTHER

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Lapner, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

2011-352

Identifier Type: -

Identifier Source: org_study_id