A Randomized Clinical Trial Comparing Open to Mini-Open Rotator Cuff Repair for Full-Thickness Rotator Cuff Tears.
Prospective Randomized Study Comparing Open Acromioplasty and Rotator Cuff Repair Versus Arthroscopic Acromioplasty and Mini-Open Rotator Cuff Repair.
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 1N4
- University of Calgary Sport Medicine Centre
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British Columbia
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New Westminster, British Columbia, Canada, V3L 3W7
- Royal Columbian Hospital
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Ontario
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London, Ontario, Canada, N6A 3K7
- Fowler Kennedy Sport Medicine Centre
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Toronto, Ontario, Canada, M4Y 1H1
- Sunnybrook and Women's College Health Sciences Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Open Repair
|
A standard vertical incision was made over the anterolateral aspect of the acromion.
The deltoid muscle was split and stripped off the anterior aspect of the acromion.
The anterior and inferior aspect of the acromion was removed.
The coracoacromial ligament was excised.
Repair of the tear in the cuff tendon(s) was accomplished by suturing leading edge of the tear into the greater tuberosity of the humerus at or near the original site of insertion of the cuff to bone.
Trans-osseous sutures, suture anchors and tendon to tendon suture repair techniques were employed for a secure repair with the arm at the side.
The surgeon was allowed to use whatever method(s) to create a secure repair.
The deltoid was securely reattached to the acromion with the deltoid fascia repaired down the split.
Other Names:
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|
Active Comparator: Mini-open Repair
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A standard arthroscopic gleno-humeral arthroscopy was performed followed by an arthroscopic acromioplasty.
Three standard arthroscopic portals were used.
The lateral portal was centered in line with the cuff tear, and incorporated into the mini-open incision.
Initially, a partial bursectomy was performed to improve visualization.
The inferior surface of the anterior acromion and the coracoacromial ligament were removed.
Following the arthroscopic acromioplasty, a 3-4cm lateral incision was performed in the area of the lateral portal.
The deltoid muscle was split longitudinally to expose the tear in the rotator cuff.
The tear was repaired in a similar manner to the open repair with tendon to tendon sutures, trans-osseous sutures and with suture anchors.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rotator Cuff Quality of Life Questionnaire (RC-QOL)
Time Frame: Baseline, 3, 6, 12, 24 months
|
Baseline, 3, 6, 12, 24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
American Shoulder and Elbow Surgeons Score
Time Frame: Baseline, 3, 6, 12, 24 months
|
Baseline, 3, 6, 12, 24 months
|
|
Shoulder Rating Questionnaire
Time Frame: Baseline, 3, 6, 12, 24 months
|
Baseline, 3, 6, 12, 24 months
|
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Functional Shoulder Elevation Test
Time Frame: Baseline, 6, 12, 24 months
|
Baseline, 6, 12, 24 months
|
|
Range of motion
Time Frame: Baseline, 3, 6, 12, 24 months
|
Baseline, 3, 6, 12, 24 months
|
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Strength
Time Frame: Baseline, 3, 6, 12, 24 months
|
Baseline, 3, 6, 12, 24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10368
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