Arthroscopy: The Journal of Arthroscopic & Related Surgery
Original ArticleA Randomized Clinical Trial Evaluating Plasma Rich in Growth Factors (PRGF-Endoret) Versus Hyaluronic Acid in the Short-Term Treatment of Symptomatic Knee Osteoarthritis
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.