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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00782197
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : October 4, 2010
Information provided by:
Biotechnology Institute IMASD

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

Condition or disease Intervention/treatment Phase
Joint Disease Device: PRGF Intraarticular injection Device: Hyaluronic Acid Intraarticular injection Phase 4

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of the Infiltration of Autologous Plasma Rich in Growth Factors (PRGF) in the Symptomatic Treatment of Knee Osteoarthritis
Study Start Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders

Arm Intervention/treatment
Experimental: 1
Device: PRGF Intraarticular injection
Three consecutive PRGF injections each one week apart.

Active Comparator: 2
Hyaluronic Acid
Device: Hyaluronic Acid Intraarticular injection
Three consecutive Hyaluronic acid (EUFLEXXA) injections, each one week apart.

Primary Outcome Measures :
  1. Improvement in Womac pain subscore and visual analogue score from baseline and changes in Lequesne's algofunctional index. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00782197

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UCA (Unidad de Cirugía Artroscopica Mikel Sanchez.) Clinica USP La Esperanza.
Vitoria, Alava, Spain
Hospital Donostia.
San Sebastian, Gipuzkoa, Spain
Policlinica Gipuzkoa
San Sebastian, Gipuzkoa, Spain
Sponsors and Collaborators
Biotechnology Institute IMASD
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Principal Investigator: Mikel Sanchez UCA (Unidad de Cirugía Artroscópica Mikel Sanchez). USP Clínica la Esperanza. C/LA Esperanza 3, 01002 Vitoria (Alava)SPAIN.
Study Director: Jaime Usabiaga Hospital Donostia
Study Director: Javier Albillos Policlinica Gipuzkoa
Additional Information:
Layout table for additonal information Identifier: NCT00782197    
Other Study ID Numbers: BTI-01-EC/07/ART
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: October 4, 2010
Last Verified: October 2010
Keywords provided by Biotechnology Institute IMASD:
autologous plasma
plasma preparations
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents