Pilot study to evaluate combination of intraosseous with intra-articular infiltrations of plasma rich in growth factors (PRGF®-Endoret®) in the treatment of knee osteoarthritis.

Conditions: Knee osteoarthritis
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2013-003982-32-ES

Lead Sponsor: Arthroscopic Surgery Unit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients of both sexes aged 40 to 72 years.
Monocomparitemental internal tibiofemoral osteoarthritis knee diagnosed by radiological clinical study.
Joint Pain or above 2.5 VAS points.
Radiographic severity grades 3 and 4 according to the scale Ahlbäck.
Values ??of Body Mass Index between 20 and 30.
Possibility for observation during the follow up period.
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Bilateral knee osteoarthritis in both knees that requires infiltration
BMI> 30
Polyarticular disease diagnosed.
Severe mechanical deformity (4th varus and16th valgus bidiafisarios )
Arthroscopy in the last year prior.
Intraarticular infiltration of hyaluronic acid in the past 6 months.
Systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis).
Poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%)
Blood disorders (thrombopathy, thrombocytopenia, anemia with Hb <9).
Be undergoing immunosuppressive therapy and / or warfarin.
Treatment with corticosteroids during the 6 months prior to inclusion in the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and safety of PRGF ®-Endoret ® in patients with knee osteoarthritis, by means of combination of intraosseous with intra-articular injections.;Secondary Objective: Not applicable;Primary end point(s): Clinically significant pain improvement according to KOOS scale (Knee injury and Osteoarthritis Outcome Scoredolor);Timepoint(s) of evaluation of this end point: Sixth month

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Symptom improvement clinically significant (KOOS).<br>Improved performance of daily activities clinically significant (KOOS).<br>Improved quality of life clinically significant (SF-12v2).<br>Degree of joint mobility (mobility Arco determined by goniometer)<br>Paracetamol consumption;Timepoint(s) of evaluation of this end point: Sixth month