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

This study has been completed.
Sponsor:
Information provided by:
Biotechnology Institute IMASD
ClinicalTrials.gov Identifier:
NCT00782197
First received: October 30, 2008
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

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


Condition Intervention Phase
Joint Disease
Device: PRGF Intraarticular injection
Device: Hyaluronic Acid Intraarticular injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Biotechnology Institute IMASD:

Primary Outcome Measures:
  • Improvement in Womac pain subscore and visual analogue score from baseline and changes in Lequesne's algofunctional index. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of joint function (change in Womac OA index total score and function and stiffness subscores.) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in Quality of life (SF-12 questionnaire). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in Degree of joint mobility.(determined by goniometer). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Complications and/or adverse effects. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: January 2008
Arms Assigned Interventions
Experimental: 1
PRGF
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782197

Locations
Spain
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
Investigators
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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00782197     History of Changes
Other Study ID Numbers: BTI-01-EC/07/ART
Study First Received: October 30, 2008
Last Updated: October 1, 2010
Health Authority: Spain: Ethics Committee

Keywords provided by Biotechnology Institute IMASD:
osteoarthritis
knee
PRGF
autologous plasma
plasma preparations
treatment

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Osteoarthritis, Knee
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases
Mitogens
Hyaluronic Acid
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014