• Sports health · Jan 2015

    A Double-Blinded Placebo Randomized Controlled Trial Evaluating Short-term Efficacy of Platelet-Rich Plasma in Reducing Postoperative Pain After Arthroscopic Rotator Cuff Repair: A Pilot Study.

    • Alisha Hak, Krishan Rajaratnam, Olufemi R Ayeni, Jaydeep Moro, Devin Peterson, Sheila Sprague, and Mohit Bhandari.
    • Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
    • Sports Health. 2015 Jan 1;7(1):58-66.

    BackgroundWe aimed to determine whether patients with arthroscopically repaired rotator cuff (RC) tears would have reduced pain and improved function after ultrasound-guided platelet-rich plasma (PRP) injections compared with placebo injection.HypothesisPRP compared with placebo (saline) was more effective in reducing pain at the site of an RC injury that has undergone arthroscopic repair.Study DesignRandomized controlled trial.Level Of EvidenceLevel 2.MethodsWe conducted a 2-centered, blinded, randomized controlled trial comparing the level of pain in patients undergoing arthroscopic repair. Patients were randomized to either PRP or saline (placebo). They received 2 ultrasound-guided injections of the randomized product: 1 intraoperatively and 1 at 4 weeks postoperatively. The primary outcome measure was shoulder pain demonstrated using a visual analog scale (VAS) at 6 weeks postoperatively. Secondary outcomes included the EuroQol-5 Dimensions (EQ-5D); the Western Ontario Rotator Cuff Index (WORC); and the Disabilities of the Arm, Shoulder, and Hand Score (DASH), as well as adverse events and revision surgeries. Patients were assessed clinically preoperatively and at 2, 4, and 6 weeks postsurgery. A prespecified interim analysis was conducted after 50% of patients were recruited and followed.ResultsWe recruited 25 patients when interim power analysis led to an early trial termination. Follow-up was 96%. The mean difference between groups was not statistically significant (-1.81; 95% CI, -4.3 to 1.2; P = 0.16). The EQ-5D, WORC, and DASH scores also did not show significant differences between groups at week 6 (P = 0.5, 0.99, and 0.9, respectively). There were no revision surgeries, and 4 adverse events (3 PRP, 1 saline).ConclusionThere was no statistical difference in outcome measures when augmenting arthroscopically repaired RC tears with PRP.Clinical RelevanceIdentifying therapies that improve outcomes in patients with RC tears remains a challenge and deserves ongoing investigation.

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