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Completed

NCT Number: NCT00782197

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

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

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Key information

Age range

40 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UCA (Unidad de Cirugía Artroscopica Mikel Sanchez.) Clinica USP La Esperanza., Vitoria-Gasteiz, Alava, Spain

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About this study

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 cells. PRGF is a biological delivery system of a complex mixture of bioactive proteins essential to natural repair including anabolic factors for cartilage such as transforming growth factor-β1 (TGF-β1), platelet-derived growth factor (PDGF) and insulin-like growth factor (IGF-I). The potential of PRGF to enhance the limited capacity of cartilage to repair itself encouraged the idea of treating degenerative joint conditions with this autologous preparation.

The present study was undertaken to assess the efficacy and safety of the intra-articular injection of PRGF and to obtain useful information about the clinical effects. Since pain is the most pressing problem facing people with OA, a significant improvement in pain would indicate the potential of the proposed treatment. We will also evaluate functionality and quality of life. In addition we will examine changes in novel serum and synovial fluid biomarkers and their correlation with MRI-based parameters in a subgroup of patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

PRGF Intraarticular injection

Device

Three consecutive PRGF injections each one week apart.

Hyaluronic Acid Intraarticular injection

Device

Three consecutive Hyaluronic acid (EUFLEXXA) injections, each one week apart.

Primary outcomes

  1. Improvement in Womac pain subscore and visual analogue score from baseline and changes in Lequesne's algofunctional index.

    Time frame: 6 months

Secondary outcomes

  1. Improvement of joint function (change in Womac OA index total score and function and stiffness subscores.)

    Time frame: 6 months

  2. Changes in Quality of life (SF-12 questionnaire).

    Time frame: 6 months

  3. Changes in Degree of joint mobility.(determined by goniometer).

    Time frame: 6 months

  4. Complications and/or adverse effects.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Biotechnology Institute IMASD

Industry

Registry information

Official study title

Efficacy and Safety of the Infiltration of Autologous Plasma Rich in Growth Factors (PRGF) in the Symptomatic Treatment of Knee Osteoarthritis

Important dates

Study start
2008
First posted
Oct 31, 2008
Registry last updated
Oct 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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