FindTrial
Sign In

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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-003982-32-ES
Enrollment
Unknown
Registered
2013-11-12
Start date
2013-12-26
Completion date
Unknown
Last updated
2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis

Interventions

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(

Sponsors

Arthroscopic Surgery Unit
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Spain

Contacts

Public ContactResearch Information

Arthrosrcopic Surgery Unit

uca_investigacion@quiron.es0034649328071

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026