Sling Is Not Inferior to Brace Immobilization After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial.

Abstract

To compare the safety and efficacy of immobilizing the upper limb with a brace versus a less-constrained sling in the rehabilitation after arthroscopic rotator cuff repair (ARCR), by documenting clinical and radiologic results. ARCR was performed in 110 patients (54.9 ± 8.3 years) randomized in group A, using a brace for 6 weeks after surgery (3 weeks day and night then 3 weeks only at night), and group B, using a simple sling for 2 weeks only. Patients were evaluated at baseline, 6 weeks, and 3 and 6 months. Functional outcomes were range of motion, strength, Disabilities of the Arm, Shoulder and Hand score, and Constant-Murley Score (CMS). Pain was assessed with a visual analog scale and quality of life with the SF-36 questionnaire. The primary outcome was the CMS at 6 months. At 6 months, 3-Tesla magnetic resonance imaging was performed to document the status of the rotator cuff repair. The minimal clinically important difference was also analyzed. Both groups A and B showed a worsening at 6 weeks and an improvement at 3 and 6 months of Disabilities of the Arm, Shoulder and Hand and CMS, as well as a significant visual analog scale decrease at every follow-up (P < .005). SF-36 showed a different trend: General health improved at 6 weeks, then decreased at 3 months, and increased again at 6 months. No difference was retrieved between the 2 groups at any follow-up in terms of pain, functional, and general health scores. The minimal clinically important difference for the primary outcome was 14.5 points and was reached in 56.5% and 61.2% of patients in the sling and brace group, respectively. The evaluation of magnetic resonance imaging scans identified 5 patients in each group with a supraspinatus tendon re-rupture, with no statistical difference in the re-rupture rate between the 2 groups. This randomized controlled trial demonstrated that ARCR postoperative sling immobilization was not inferior to immobilization with a brace, having no differences in terms of functional scores, pain levels, general health, and risk of tendon re-rupture. Level I, high-quality randomized controlled trial (designed as a therapeutic study investigating the results of treatment) with statistically significant difference.