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

Sponsor

University of Calgary (Other)

Overall Status

Completed

CT.gov ID

NCT00251147

Collaborator

Workers' Compensation Board, Alberta (Other), Canadian Orthopaedic Foundation (Other)

Enrollment

Locations

Arms

Duration (Months)

18.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tear	Procedure: Open acromioplasty with rotator cuff repair Procedure: Arthroscopic acromioplasty with mini-open repair	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

73 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prospective Randomized Study Comparing Open Acromioplasty and Rotator Cuff Repair Versus Arthroscopic Acromioplasty and Mini-Open Rotator Cuff Repair.

Study Start Date :

Mar 1, 1999

Actual Primary Completion Date :

Oct 1, 2005

Actual Study Completion Date :

Oct 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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. Other Names: Mini-open repair Scope mini-open

Arm

Intervention/Treatment

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 Names:

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.

Other Names:

Mini-open repair

Scope mini-open

Outcome Measures

Primary Outcome Measures

Rotator Cuff Quality of Life Questionnaire (RC-QOL) [Baseline, 3, 6, 12, 24 months]

Secondary Outcome Measures

American Shoulder and Elbow Surgeons Score [Baseline, 3, 6, 12, 24 months]
Shoulder Rating Questionnaire [Baseline, 3, 6, 12, 24 months]
Functional Shoulder Elevation Test [Baseline, 6, 12, 24 months]
Range of motion [Baseline, 3, 6, 12, 24 months]
Strength [Baseline, 3, 6, 12, 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Calgary Sport Medicine Centre	Calgary	Alberta	Canada	T2N 1N4
2	Royal Columbian Hospital	New Westminster	British Columbia	Canada	V3L 3W7
3	Fowler Kennedy Sport Medicine Centre	London	Ontario	Canada	N6A 3K7
4	Sunnybrook and Women's College Health Sciences Centre	Toronto	Ontario	Canada	M4Y 1H1

Sponsors and Collaborators

University of Calgary
Workers' Compensation Board, Alberta
Canadian Orthopaedic Foundation

Investigators

Principal Investigator: Robert Hollinshead, MD, FRCSC, University of Calgary Sport Medicine Centre
Principal Investigator: Nicholas Mohtadi, MD, FRCSC, University of Calgary Sport Medicine Centre