A Randomized Clinical Trial Comparing Open to Mini-Open Rotator Cuff Repair for Full-Thickness Rotator Cuff Tears.

University of Calgary

Status

Completed

Conditions

Rotator Cuff Tear

Treatments

Procedure: Arthroscopic acromioplasty with mini-open repair

Procedure: Open acromioplasty with rotator cuff repair

Study type

Interventional

Funder types

Other

Identifiers

NCT00251147

10368

Details and patient eligibility

About

This study compares standard open rotator cuff repair versus arthroscopic mini-open rotator cuff repair by measuring the disease-specific quality of life at 2 years in patients with full thickness rotator cuff tears.

Hypothesis: There is no difference in disease-specific quality of life outcome at two years between open versus arthroscopic mini-open repair for patients with full-thickness rotator cuff tears.

Full description

Rotator cuff injury affects a diverse group of patients and leads to significant disability with respect to lost time from work and the inability to play sports, thereby affecting the individual's quality of life.

The standard treatment for full-thickness rotator cuff repair is with an open acromioplasty procedure. An alternative procedure for a full-thickness rotator cuff tear is with a combined procedure of arthroscopic acromioplasty and mini-open repair, which has the potential advantages of a preserved deltoid origin, lower perioperative morbidity, shorter hospital stays and less soft tissue dissection. The progression towards arthroscopic repair requires a comparison to the standard, open procedure for full-thickness rotator cuff tears, using validated outcomes in a randomized fashion.

This study is designed as a multi-centre randomized controlled trial with a priori sample size calculation of 28 patients per group. Patients presenting with unremitting pain, failed conservative treatment of at least 3 months, weakness of the rotator cuff and positive imaging indicating a full-thickness rotator cuff tear are eligible for the study. Previous surgery on the affected shoulder and massive rotator cuff tears are excluded. Patients are randomized using computer-generated block randomization, stratified by surgeon, to either open or mini-open rotator cuff repair.

Disease-specific quality of life is assessed using the validated Rotator Cuff Quality of Life Questionnaire, a self-administered, 34-item questionnaire designed specifically to assess patients before and after surgery. It utilizes a visual analog scale scored out of 100, with a higher score reflecting a better quality of life.

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with unremitting pain in the affected shoulder who have failed conservative treatment for at least 3 months
Weakness of rotator cuff (MRC grades 4-, 4 or 4+)
Positive diagnostic imaging on the affected shoulder indicating a full-thickness rotator cuff tear which may include arthrogram, ultrasound or MRI
Age > 18 years
English speaking

Exclusion criteria

A massive rotator cuff tear as demonstrated by Grade 3 or less muscle strength on testing internal and external rotation of the affected shoulder
Previous surgery to the affected shoulder