Leukocyte-Poor Platelet-Rich Plasma as an Adjuvant to Arthroscopic Rotator Cuff Repair Reduces the Retear Rate But Does Not Improve Functional Outcomes: A Double-Blind Randomized Controlled Trial.

ABSTRACT

BACKGROUND: Whether the use of PRP as an adjuvant of rotator cuff repairs leads to improved tendon healing and better functional outcomes remains unclear in clinical evidence. PURPOSE: The main purpose of this study was to assess whether the use of leukocyte-poor platelet-rich plasma (LP-PRP) as an adjuvant to arthroscopic rotator cuff repair (ARCR) decreases the rate of retears compared with a control group. The secondary objective was to analyze whether LP-PRP improves patient-reported outcomes. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: This was a double-blind randomized controlled trial at a single center. A consecutive series of 96 patients with rotator cuff tears <3 cm were enrolled and randomly allocated to the control group (double-row suture-bridge ARCR alone [n = 48]) and the PRP group (double-row suture-bridge repair, followed by 1 LP-PRP injection during surgery [n = 48]). The visual analog scale (VAS) for pain, the American Shoulder and Elbow Surgeons (ASES) score, the Single Assessment Numeric Evaluation (SANE), and the Pittsburgh Sleep Quality Index (PSQI) were administered preoperatively and at 6- and 12-month follow-up. Magnetic resonance imaging (MRI) was performed to evaluate tendon integrity at 6-month follow-up. Both patients and assessors were blinded to the intervention received during surgery. RESULTS: The mean patient age was 56.1 ± 2.98 years. Of the 96 patients, 90 had MRI performed at 6 months after surgery (94% radiological follow-up). The retear rate in the PRP group was 15.2% (7/46 [95% CI, 6%-28%]), which was lower than that in the control group of 34.1% (15/44 [95% CI, 20%-49%]) (P = .037). Therefore, the risk ratio of ruptures in patients exposed to LP-PRP was 0.44 (95% CI, 0.2-0.9; P = .037). Overall, the ASES, VAS, SANE, and PSQI scores showed a statistical improvement after surgery (P < .001). There were no significant differences in functional scores between the groups. Most of the patients exceeded the minimal clinically important difference for the ASES, SANE, and VAS without significant differences between the groups. CONCLUSION: In patients with rotator cuff tears <3 cm undergoing double-row suture-bridge repair, a 5-mL dose of LP-PRP injected at the tendon-bone interface significantly reduced the retear rate. However, the use of LP-PRP in terms of postoperative pain and patient-reported outcomes failed to show clinically meaningful effects. REGISTRATION NCT04703998 (ClinicalTrials.gov identifier).