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A Randomized Clinical Trial Evaluating Plasma Rich in Growth Factors (PRGF-Endoret) Versus Hyaluronic Acid in the Short-Term Treatment of Symptomatic Knee Osteoarthritis

      Purpose

      This multicenter, double-blind clinical trial evaluated and compared the efficacy and safety of PRGF-Endoret (BTI Biotechnology Institute, Vitoria-Gasteiz, Spain), an autologous biological therapy for regenerative purposes, versus hyaluronic acid (HA) as a short-term treatment for knee pain from osteoarthritis.

      Methods

      We randomly assigned 176 patients with symptomatic knee osteoarthritis to receive infiltrations with PRGF-Endoret or with HA (3 injections on a weekly basis). The primary outcome measure was a 50% decrease in knee pain from baseline to week 24. As secondary outcomes, we also assessed pain, stiffness, and physical function using the Western Ontario and McMaster Universities Osteoarthritis Index; the rate of response using the criteria of the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI); and safety.

      Results

      The mean age of the patients was 59.8 years, and 52% were women. Compared with the rate of response to HA, the rate of response to PRGF-Endoret was 14.1 percentage points higher (95% confidence interval, 0.5 to 27.6; P = .044). Regarding the secondary outcome measures, the rate of response to PRGF-Endoret was higher in all cases, although no significant differences were reached. Adverse events were mild and evenly distributed between the groups.

      Conclusions

      Plasma rich in growth factors showed superior short-term results when compared with HA in a randomized controlled trial, with a comparable safety profile, in alleviating symptoms of mild to moderate osteoarthritis of the knee.

      Level of Evidence

      Level I, randomized controlled multicenter trial.
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      Linked Article

      • Misreporting of a Plasma-Rich-in-Growth-Factors Trial on Knee Osteoarthritis
        ArthroscopyVol. 36Issue 3
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          As attentive readers of your prestigious journal, we are deeply concerned by a potentially serious case of misreporting affecting Arthroscopy. Early in 2019, our publicly funded research team was commissioned to assess the evidence on platelet-rich plasma and analogues in traumatology. We retrieved, among the appraised publications, the high-impact article published by Sánchez et al.1 evaluating plasma rich in growth factors versus hyaluronic acid for knee osteoarthritis. We asked the authors for additional information, namely the protocol, clinical study report (or similar final report), and ethics committee approval.
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