A RANDOMIZED CLINICAL TRIAL COMPARING MINI-OPEN TO OPEN ROTATOR CUFF REPAIR

Abstract

This randomized clinical trial utilizing the validated rotator cuff disease specific quality of life outcome measure (RC-QOL) and adequate power demonstrates no difference in outcome for full thickness rotator cuff tears comparing open to mini-open surgical techniques.

The purpose of the study was to compare standard open rotator cuff repair versus mini-open rotator cuff repair by measuring the disease specific quality of life in patients with rotator cuff injury.

This randomized clinical trial utilizing a validated disease specific outcome measure and adequate power demonstrates no difference in outcome for full thickness rotator cuff tears comparing open to mini-open surgical techniques.

The miniopen approach utilizing an arthroscoic acromioplasty provides no additional beneifit to the patient undergoing a rotator cuff repair.

The mean one year RC-QOL score for the open and mini-open groups were 85.3 (SD = 15.6) and 87.4 (SD = 12.0) out of a maximum of one hundred, respectively. This difference was not statistically significant (p = 0.572).

Seventy-two patients (forty-eight males/twenty-four females) with an average age of 56.4 years (thirty-three to eighty-two years) consented to participate in the study. Inclusion criteria involved: unremitting pain, failed conservative treatment of at least three months, weakness of rotator cuff, and positive diagnostic imaging indicating a full-thickness rotator cuff tear. Massive rotator cuff tears were excluded.

Prior to surgery, patients were randomized to either open or mini-open rotator cuff repair. Patients were assessed and outcomes were collected at three, six and twelve months after surgery. Primary Outcome Measure: Patient quality of life was quantified using the validated disease specific, reliable and responsive Rotator Cuff Quality of Life Questionnaire (RC-QOL) measured on a one hundred point visual analogue scale format. Secondary Outcomes: Range of motion, strength, American Shoulder and Elbow Surgeons Score, and the Shoulder Rating Questionnaire.