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.
Copyright remains with the authors and publisher.
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.
Copyright remains with the authors and publisher.