Question: In patients who have full-thickness rotator cuff tears and in whom nonsurgical treatment has failed, does standard open acromioplasty with rotator cuff repair or arthroscopic acromioplasty with mini-open rotator cuff repair lead to better quality of life?
Design: Randomized (allocation concealed), blinded (Functional Shoulder Elevation Test [FSET] outcome assessor) controlled trial with 2-year follow-up.
Setting: University of Calgary.
Patients: 73 English-speaking patients who were =18 years of age, had unremitting pain in the affected shoulder, had failed nonsurgical treatment of =3 months, had weakness of the rotator cuff (Medical Research Council grade 4-, 4, or 4+), and had a diagnostic imaging result confirming a full-thickness rotator cuff tear. Exclusion criteria included a muscle strength grade of =3 for the affected shoulder and previous surgery to the affected shoulder. 82% of patients (mean age 57 y, 67% men) completed the 2-year assessment.
Intervention: Patients were allocated to open acromioplasty and rotator cuff repair (n = 37) or to arthroscopic acromioplasty and mini-open rotator cuff repair (n = 36).
Main outcome measures: The primary outcome measure was the Rotator Cuff-Quality of Life (RC-QOL) score (34 items, 100-point visual analog scale format; a higher score indicates better quality of life). Secondary outcome measures were performance on the American Shoulder and Elbow Surgeons (ASES) Shoulder Index (range, 0 to 100 points, 100 = best possible outcome), the Shoulder Rating Questionnaire (SRQ) score (total score, 100), and the FSET score (range, 0 [inability to lift weight because of pain, discomfort, or weakness] to 100 [no pain or weakness]).
Main results: Analysis was by intention to treat. At 3 and 6 months, patients in the mini-open repair group had higher RC-QOL scores than patients in the open repair group. The groups were not different at 1 and 2 years (Table). The change from baseline to 3 months in RC-QOL score was greater in the mini-open repair group than in the open repair group (25.4 vs 13.9, p = 0.05). Change from baseline did not differ between groups at the other follow-up time points. Both the mini-open and open repair groups improved over time according to the secondary outcome measurements. The ASES score was significantly higher in the mini-open repair group at 3 and 6 months, but the clinical importance of this difference was unclear.
Conclusions: In patients who have full-thickness rotator cuff tears and in whom nonsurgical treatment has failed, quality-of-life measures at 3 months were higher in patients who received mini-open rotator cuff repair than in those who received the standard procedure. No difference in outcomes was found at 1 and 2 years.
This methodologically sound clinical trial sought to answer a clinically relevant question. The authors are to be congratulated in the organization and completion of the trial in which only 3 patients were lost to follow-up. Although the study involved 4 centers and 6 surgeons over a 5-year time period, it is evident that most of the patients were treated at 1 of the 4 centers.
Unfortunately, understanding the clinical relevance of the findings was not as easy as confirming and lauding its rigorous scientific methodology. Patients, clinicians, and insurers would wish to know whether the observed differences in the mini-open outcomes at 3 months were reflected in decreased analgesic requirements and an earlier return to sports, work, and domestic duties and whether there was a long-term need for activity modifications. While improved outcome scores suggest improved function, there is a need for clearer communication of the meaning of these scores to surgeons and patients.
Surgeons performing either conventional open or arthroscopic acromioplasty with mini-open rotator cuff repair for full-thickness rotator cuff tears should be reassured by the satisfactory long-term outcomes of both procedures. Future studies should include additional information that will help all stakeholders to interpret and determine the clinical relevance of the patient-derived standardized outcome data.