Clinical trial NCT00251147: A Randomized Clinical Trial Comparing Open to Mini-Open Rotator Cuff Repair for Full-Thickness Rotator Cuff Tears.
Official title: Prospective Randomized Study Comparing Open Acromioplasty and Rotator Cuff Repair Versus Arthroscopic Acromioplasty and Mini-Open Rotator Cuff Repair.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: rotator cuff
open
arthroscopic
mini-open
acromioplasty
quality of life
shoulder
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Workers' Compensation Board, Alberta
name: Canadian Orthopaedic Foundation
First posted: 2005-11-09
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rotator Cuff Quality of Life Questionnaire (RC-QOL)
timeFrame: Baseline, 3, 6, 12, 24 months
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons Score
timeFrame: Baseline, 3, 6, 12, 24 months
measure: Shoulder Rating Questionnaire
timeFrame: Baseline, 3, 6, 12, 24 months
measure: Functional Shoulder Elevation Test
timeFrame: Baseline, 6, 12, 24 months
measure: Range of motion
timeFrame: Baseline, 3, 6, 12, 24 months
measure: Strength
timeFrame: Baseline, 3, 6, 12, 24 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary Sport Medicine Centre
state: Alberta
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: London
country: Canada
facility: Fowler Kennedy Sport Medicine Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook and Women's College Health Sciences Centre
state: Ontario
Study officials:
affiliation: University of Calgary Sport Medicine Centre
name: Robert Hollinshead, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary Sport Medicine Centre
name: Nicholas Mohtadi, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: