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

NACompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

March 31, 1999

Primary Completion Date

October 31, 2005

Study Completion Date

October 31, 2005

Conditions
Rotator Cuff Tear
Interventions
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.

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.

Trial Locations (4)

T2N 1N4

University of Calgary Sport Medicine Centre, Calgary

V3L 3W7

Royal Columbian Hospital, New Westminster

N6A 3K7

Fowler Kennedy Sport Medicine Centre, London

M4Y 1H1

Sunnybrook and Women's College Health Sciences Centre, Toronto

All Listed Sponsors
collaborator

Workers' Compensation Board, Alberta

OTHER

collaborator

Canadian Orthopaedic Foundation

OTHER

lead

University of Calgary

OTHER

NCT00251147 - A Randomized Clinical Trial Comparing Open to Mini-Open Rotator Cuff Repair for Full-Thickness Rotator Cuff Tears. | Biotech Hunter | Biotech Hunter