A Randomized Clinical Trial Comparing Open to Mini-Open Rotator Cuff Repair for Full-Thickness Rotator Cuff Tears.
|ClinicalTrials.gov Identifier: NCT00251147|
Recruitment Status : Completed
First Posted : November 9, 2005
Last Update Posted : January 17, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tear||Procedure: Open acromioplasty with rotator cuff repair Procedure: Arthroscopic acromioplasty with mini-open repair||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Study Comparing Open Acromioplasty and Rotator Cuff Repair Versus Arthroscopic Acromioplasty and Mini-Open Rotator Cuff Repair.|
|Study Start Date :||March 1999|
|Actual Primary Completion Date :||October 2005|
|Actual Study Completion Date :||October 2005|
|Active Comparator: Open Repair||
Procedure: Open acromioplasty with rotator cuff 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 Name: Open repair
|Active Comparator: Mini-open Repair||
Procedure: Arthroscopic acromioplasty with mini-open repair
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.
- Rotator Cuff Quality of Life Questionnaire (RC-QOL) [ Time Frame: Baseline, 3, 6, 12, 24 months ]
- American Shoulder and Elbow Surgeons Score [ Time Frame: Baseline, 3, 6, 12, 24 months ]
- Shoulder Rating Questionnaire [ Time Frame: Baseline, 3, 6, 12, 24 months ]
- Functional Shoulder Elevation Test [ Time Frame: Baseline, 6, 12, 24 months ]
- Range of motion [ Time Frame: Baseline, 3, 6, 12, 24 months ]
- Strength [ Time Frame: Baseline, 3, 6, 12, 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251147
|University of Calgary Sport Medicine Centre|
|Calgary, Alberta, Canada, T2N 1N4|
|Canada, British Columbia|
|Royal Columbian Hospital|
|New Westminster, British Columbia, Canada, V3L 3W7|
|Fowler Kennedy Sport Medicine Centre|
|London, Ontario, Canada, N6A 3K7|
|Sunnybrook and Women's College Health Sciences Centre|
|Toronto, Ontario, Canada, M4Y 1H1|
|Principal Investigator:||Robert Hollinshead, MD, FRCSC||University of Calgary Sport Medicine Centre|
|Principal Investigator:||Nicholas Mohtadi, MD, FRCSC||University of Calgary Sport Medicine Centre|