• Mikel Sánchez, Nicolás Fiz, Juan Azofra, Jaime Usabiaga, Enmanuel Aduriz Recalde, Antonio Garcia Gutierrez, Javier Albillos, Ramón Gárate, Jose Javier Aguirre, Sabino Padilla, Gorka Orive, and Eduardo Anitua.
• Unidad Cirugía Artroscópica (USP Clínica la Esperanza), Vitoria, Spain.
• Arthroscopy. 2012 Aug 1; 28 (8): 1070-8.

PurposeThis 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.MethodsWe 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.ResultsThe 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.ConclusionsPlasma 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 EvidenceLevel I, randomized controlled multicenter trial.Copyright © 2012 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

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