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

https://doi.org/10.1016/j.arthro.2012.05.011Get rights and content

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.

Section snippets

Methods

The study was carried out in accordance with the international standards on clinical trials: Real Decreto 223/2004, Declaration of Helsinki in its latest revised version (Tokyo, Japan; 2004), and Good Clinical Practice Regulations (International Conference for Harmonization). The study protocol was reviewed and approved by the Reference Ethic Committee. All patients provided written informed consent before entry into the study.

Results

A total of 187 patients were screened, and 176 underwent randomization (Fig 1). The most common reason for exclusion included a BMI higher than 32 (6 patients), the inability to meet radiographic criteria (4 patients), and a genu varus deformity of the knee (1 patient). A slightly higher percentage of patients were women (52%), with a mean age of 59.8 years and a mean BMI of 28. The groups were well balanced in terms of age, gender, BMI, percentage of patients with primary arthritis,

Discussion

We conducted the first randomized, double-blind, HA-controlled, multicenter trial to rigorously evaluate the efficacy and safety of intra-articular injections of PRGF-Endoret in the treatment of pain caused by OA of the knee. Three injections of PRGF-Endoret, an autologous pool of growth factors and fibrin scaffold biomaterial, resulted in clinically significant reductions in knee pain, stiffness, and in improving the physical function in patients with knee OA. The analysis of the primary

Conclusions

PRGF 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 OA of the knee.

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    The authors report that they have no conflicts of interest in the authorship and publication of this article.

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