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Status:

COMPLETED

Autologous Plasma Rich in Growth Factors (PRGF) Treating the Symptomatic Knee OA

Lead Sponsor:

Biotechnology Institute IMASD

Conditions:

Joint Disease

Eligibility:

All Genders

40-72 years

Phase:

PHASE4

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of PRGF infiltrations in the treatment of knee osteoarthritis.

Detailed Description

Several studies have shown the positive effects of the autologous "Preparation Rich in Growth Factors" (PRGF) in different clinical situations involving connective tissues and also in OA synovial cell...

Eligibility Criteria

Inclusion

  • Patients of both sexes and aged between 40 and 72 years.
  • Diagnosed with osteoarthritis of the knee by radiological image.
  • Pain in the joint equal to or greater than 2.5 points in EAV.
  • Radiological severity:Value in the Ahlback score 3 or less.
  • Body mass index between 20 and 30.
  • Possibility for observation during follow-up period.

Exclusion

  • Bilateral Gonarthrosis requiring infiltration in both knees.
  • Body mass index greater than 30.
  • Diagnosed polyarticular disease.
  • Severe mechanical deformation.
  • Previous arthroscopy in the past year.
  • Intraarticular infiltration of hyaluronic acid in the last 6 months.
  • Rheumatic autoimmune systemic disease.
  • Poorly controlled diabetes mellitus.
  • Blood alterations.
  • Immunosuppressive treatments and/or coumarinics.
  • Treatment with steroids for 3 months prior to its inclusion in the study.
  • Treatment with nonsteroidal anti-inflammatory drugs for 15 days prior to its inclusion in the study.

Key Trial Info

Start Date :

January 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

240 Patients enrolled

Trial Details

Trial ID

NCT00782197

Start Date

January 1 2008

Last Update

October 4 2010

Active Locations (3)

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Page 1 of 1 (3 locations)

1

UCA (Unidad de Cirugía Artroscopica Mikel Sanchez.) Clinica USP La Esperanza.

Vitoria-Gasteiz, Alava, Spain

2

Hospital Donostia.

Donostia / San Sebastian, Gipuzkoa, Spain

3

Policlinica Gipuzkoa

Donostia / San Sebastian, Gipuzkoa, Spain