Sling is Not-Inferior to Brace Immobilization Following Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial.

Purpose: The aim of this study was 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 radiological results.

Methods: 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, 3 and 6 months. Functional outcomes were: range of motion, strength, Disabilities of the Arm, Shoulder and Hand score (DASH), and Constant score (CMS). Pain was assessed with a Visual Analog Scale (VAS); and quality of life with the SF36 questionnaire. The primary outcome was the CMS at 6 months. At 6 months, a 3 Tesla MRI was performed to document the status of the rotator cuff repair. The Minimal Clinically Important Difference (MCID) was also analysed.

Results: Both groups A and B showed a worsening at 6 weeks and an improvement at 3 and 6 months of DASH and CMS, as well as a significant VAS decrease at every follow-up (p<0.005). SF36 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 two groups at any follow-up in terms of pain, functional, and general health scores. The MCID 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 MRI evaluation identified 5 patients in each group with a supraspinatus tendon re-rupture, with no statistical difference in the re-rupture rate between the two groups.

Conclusions: This randomized controlled trial demonstrated that ARCR post-operative 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 Of Evidence: Level 1: High-quality randomized controlled trial (designed as a therapeutic study investigating the results of treatment) with statistically significant difference.