Knee osteoarthritis
Conditions
Sponsors
Arthroscopic Surgery Unit
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Gonarthrosis requiring infiltration in both knees BMI> 35 Mechanical deformity requiring osteotomy. Previous arthroscopy in the last year. Intra-articular injection of hyaluronic acid in the last 6 months. Systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis). Poorly controlled diabetes (glycosylated hemoglobin above 9%) Blood disorders (thrombopathy, thrombocytopenia, anemia with Hb <9). It is undergoing immunosuppressive treatments. Treatment with steroids during the 6 months prior to inclusion in the study. Patients unable to stop treatment with NSAIDs during the study. Pregnancy and lactation. Polyarticular disease diagnosed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Secondary Objective: To evaluate systemic effect 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);Timepoint(s) of evaluation of this end point: Sixth month | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Spain
Contacts
Public ContactResearch Department
Arthroscopic Surgery Unit
Outcome results
None listed