Efficacy, safety and systemic effect of intra-articular and intraosseous infiltrations of Platelet Rich Plasma in patients with knee osteoarthritis: Randomized Clinical Trial

INTERVENTION: Product Name: PRP (Obtenido por PRGF‐Endoret) Pharmaceutical Form: Solution for injection INN or Proposed INN: PRGF‐ENDORET Other descriptive name: AUTOLOGOUS PLASMA Concentration unit: ml millilitre(s) Concentration type: range Concentration number: 5‐8 Product Name: PRP (Obtenido por PRGF‐Endoret) Pharmaceutical Form: Solution for injection INN or Proposed INN: PRGF‐ENDORET Other descriptive name: AUTOLOGOUS PLASMA Concentration unit: ml millilitre(s) Concentration type: range Concentration number: 5‐8 CONDITION: Knee osteoarthritis Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: Main Objective: To evaluate the efficacy and safety of PRGF ®‐Endoret ® in patients with knee osteoarthritis, by means of combination of intraosseous with intraarticular injections. Primary end point(s): Clinically significant pain improvement according to KOOS scale (Knee; injury and Osteoarthritis Outcome Score) Secondary Objective: To evaluate systemic effect of PRGF ®‐Endoret ® in patients with knee osteoarthritis, by means of combination of intraosseous with intraarticular injections. Timepoint(s) of evaluation of this end point: Sixth month SECONDARY OUTCOME: Secondary end point(s): Symptom improvement clinically significant (KOOS).; Improved performance of daily activities clinically significant (KOOS).; Improved performance of sport activites clinically significant (KOOS).; Improved quality of life clinically significant (KOOS). Timepoint(s) of evaluation of this end point: Sixth month INCLUSION CRITERIA: Patients of both sexes aged between 40 and 85 years old. Diagnosed with osteoarthritis predominantly in the medial tibiofemoral compartment through X‐ray knee clinical study. Joint pain than or equal to 2.5 points in VAS. Radiological severity grades 1, 2, 3, 4 according to the Ahlbäck scale. Values of Body Mass Index between 20 and 35. Serological tests negative against syphilis, HIV, HBV and HCV. Possibility for observation during the monitoring period Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60