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

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.

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.

Sponsors & Collaborators

• Workers' Compensation Board, Alberta

  collaborator OTHER

• Canadian Orthopaedic Foundation

  collaborator OTHER

• University of Calgary

  lead OTHER

Principal Investigators

• Robert Hollinshead, MD, FRCSC · University of Calgary Sport Medicine Centre

• Nicholas Mohtadi, MD, FRCSC · University of Calgary Sport Medicine Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1999-03-31

Primary Completion

2005-10-31

Completion

2005-10-31

Countries

• Canada

Study Locations