Background: The benefits of platelet-rich plasma (PRP) for the treatment of rotator cuff tears remain inconclusive, as it is administered either as an adjuvant to surgical repair or as a primary infiltration without targeting the index lesion, which could dilute its effect. Purpose: To determine whether PRP infiltrations are superior to saline solution infiltrations (placebo) at improving healing, pain, and function when injected under ultrasound guidance within isolated interstitial supraspinatus tears. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: In this single-center, double-blinded, randomized controlled trial, 80 adults with symptomatic isolated interstitial tears of the supraspinatus, confirmed by magnetic resonance arthrography, were randomized to PRP or saline injections. Each patient received 2 injections with a 1-month interval. The primary outcome was the change in lesion volume, calculated on magnetic resonance arthrography, at 7 months. The secondary outcomes were improvements in shoulder pain and the Single Assessment Numerical Evaluation (SANE) score at >12 months. Results: Preoperative patient characteristics did not differ between the 2 groups. At 7 months, there were no significant differences between the PRP and control groups in terms of a decrease in lesion size (–0.3 ± 23.6 mm3 vs –8.1 ± 84.7 mm3, respectively; P = .175); reduction of pain on a visual analog scale (VAS) (–2.3 ± 3.0 vs –2.0 ± 3.0, respectively; P = .586); and improvement in SANE (16.7 ± 20.0 vs 14.9 ± 29.0, respectively; P = .650), Constant (8.6 ± 13.0 vs 10.7 ± 19.0, respectively; P = .596), and American Shoulder and Elbow Surgeons (19.5 ± 20.0 vs 21.9 ± 28.0, respectively; P = .665) scores. At >12 months, there were no significant differences between the PRP and control groups in terms of a reduction of pain on a VAS (–3.3 ± 2.6 vs –2.3 ± 3.2, respectively; P = .087) or improvement in the SANE score (24.4 ± 27.5 vs 23.4 ± 24.9, respectively; P = .846). At 19.5 ± 5.3 months, the incidence of adverse effects (pain >48 hours, frozen shoulder, extension of lesion) was significantly higher in the PRP group than the control group (54% vs 26%, respectively; P = .020). Conclusion: PRP injections within interstitial supraspinatus tears did not improve tendon healing or clinical scores compared with saline injections and were associated with more adverse events. Registration: NCT02672085 (ClinicalTrials.gov identifier).
Objectives: Patients are commonly advised to wear a sling for 4-6 weeks after rotator cuff repair (RCR) despite negative effects of early immobilization and benefits of motion rehabilitation. The study aimed to compare clinical and radiographic outcomes up to 6 months following RCR with sling immobilization and without sling immobilization. Methods: We randomized 80 patients scheduled for arthroscopic repair of small or medium superior rotator cuff tears into 2 equal groups: 'sling' and 'no-sling' groups. Passive mobilization was performed in both groups during the first 4 postoperative weeks followed by a progressive active mobilization. Patients were evaluated clinically at 10 days, 1.5, 3 and 6 months, and using ultrasound at 6 months. Uni-and multi-variable analyses were performed to determine if postoperative scores are associated with gender, age at surgery, immobilization, arm dominance, biceps procedure, resection of the distal clavicle, as well as preoperative scores. Results: The two groups had similar preoperative patient characteristics, function, or adjuvant procedures. At 10 days, there was no difference in pain among the two groups (5.2±2.3 vs 5.2±1.9, p=0.996). In comparison to the sling group, the no-sling group showed greater external rotation (23.5±15.6 vs 15.3±14.6, p=0.017) and active elevation (110.9±31.9 vs 97.0±25.0, p=0.038) at 1.5 months, as well as better active elevation (139.0±24.7 vs 125.8±24.4, p=0.015) and internal rotation (>T12 in 50% vs 27.5%, p=0.011) at 3 months. Ultrasound revealed no differences at 6 months in tendon thickness anteriorly (p=0.472) or posteriorly (p=639), bursitis (p=1.000), echogenicity (p=0.422), or repair integrity (p=0.902). Multi-variable analyses confirmed that ASES score increased with patient age (beta, 0.60; p=0.009), SANE decreased with sling immobilization (beta,-6.3; p=0.014), and that pain increased with sling immobilization (beta, 0.77; p=0.022). Conclusion: No immobilization after RCR is associated with better early mobility and functional scores in comparison to sling immobilization. Postoperative immobilization with slings may therefore not be required for patients treated for small or medium tears.
Background: Patients are commonly advised to wear a sling for 4 to 6 weeks after rotator cuff repair despite negative effects of early immobilization and benefits of motion rehabilitation. The aim of this study was to compare clinical and radiographic outcomes up to 6 months following rotator cuff repair with and without postoperative sling immobilization. Methods: We randomized 80 patients scheduled for arthroscopic repair of a small or medium superior rotator cuff tear into sling and no-sling groups (40 patients each). Passive mobilization was performed in both groups during the first 4 postoperative weeks, and this was followed by progressive active mobilization. Patients were evaluated clinically at 10 days and 1.5, 3, and 6 months and using ultrasound at 6 months. Univariable and multivariable analyses were performed to determine if postoperative scores were associated with sex, age at surgery, immobilization, arm dominance, a biceps procedure, resection of the distal part of the clavicle, or preoperative scores. Results: The sling and no-sling groups had similar preoperative patient characteristics, function, and adjuvant procedures. At 10 days, there was no difference in pain between the 2 groups (mean pain score [and standard deviation], 5.2 ± 2.3 versus 5.2 ± 1.9, p = 0.996). In comparison with the sling group, the no-sling group showed greater mean external rotation (23.5° ± 15.6° versus 15.3° ± 14.6°, p = 0.017) and active elevation (110.9° ± 31.9° versus 97.0° ± 25.0°, p = 0.038) at 1.5 months as well as better mean active elevation (139.0° ± 24.7° versus 125.8° ± 24.4°, p = 0.015) and internal rotation (T12 or above in 50% versus 28%, p = 0.011) at 3 months. Ultrasound evaluation revealed no significant differences at 6 months in tendon thickness anteriorly (p = 0.472) or posteriorly (p = 0.639), bursitis (p = 1.000), echogenicity (p = 0.422), or repair integrity (p = 0.902). Multivariable analyses confirmed that the mean American Shoulder and Elbow Surgeons (ASES) score increased with patient age (beta, 0.60; p = 0.009), the Single Assessment Numeric Evaluation (SANE) decreased with sling immobilization (beta, −6.33; p = 0.014), and pain increased with sling immobilization (beta, 0.77; p = 0.022). Conclusions: No immobilization after rotator cuff repair is associated with better early mobility and functional scores in comparison with sling immobilization. Postoperative immobilization with a sling may therefore not be required for patients treated for a small or medium tendon tear. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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