Autologous Plasma Rich in Growth Factors (PRGF) Treating the Symptomatic Knee OA
Primary Purpose
Joint Disease
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
PRGF Intraarticular injection
Hyaluronic Acid Intraarticular injection
Sponsored by
About this trial
This is an interventional treatment trial for Joint Disease focused on measuring osteoarthritis, knee, PRGF, autologous plasma, plasma preparations, treatment
Eligibility 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.
Sites / Locations
- UCA (Unidad de Cirugía Artroscopica Mikel Sanchez.) Clinica USP La Esperanza.
- Hospital Donostia.
- Policlinica Gipuzkoa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
PRGF
Hyaluronic Acid
Outcomes
Primary Outcome Measures
Improvement in Womac pain subscore and visual analogue score from baseline and changes in Lequesne's algofunctional index.
Secondary Outcome Measures
Improvement of joint function (change in Womac OA index total score and function and stiffness subscores.)
Changes in Quality of life (SF-12 questionnaire).
Changes in Degree of joint mobility.(determined by goniometer).
Complications and/or adverse effects.
Full Information
NCT ID
NCT00782197
First Posted
October 30, 2008
Last Updated
October 1, 2010
Sponsor
Biotechnology Institute IMASD
1. Study Identification
Unique Protocol Identification Number
NCT00782197
Brief Title
Autologous Plasma Rich in Growth Factors (PRGF) Treating the Symptomatic Knee OA
Official Title
Efficacy and Safety of the Infiltration of Autologous Plasma Rich in Growth Factors (PRGF) in the Symptomatic Treatment of Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Biotechnology Institute IMASD
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Disease
Keywords
osteoarthritis, knee, PRGF, autologous plasma, plasma preparations, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
PRGF
Arm Title
2
Arm Type
Active Comparator
Arm Description
Hyaluronic Acid
Intervention Type
Device
Intervention Name(s)
PRGF Intraarticular injection
Intervention Description
Three consecutive PRGF injections each one week apart.
Intervention Type
Device
Intervention Name(s)
Hyaluronic Acid Intraarticular injection
Intervention Description
Three consecutive Hyaluronic acid (EUFLEXXA) injections, each one week apart.
Primary Outcome Measure Information:
Title
Improvement in Womac pain subscore and visual analogue score from baseline and changes in Lequesne's algofunctional index.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improvement of joint function (change in Womac OA index total score and function and stiffness subscores.)
Time Frame
6 months
Title
Changes in Quality of life (SF-12 questionnaire).
Time Frame
6 months
Title
Changes in Degree of joint mobility.(determined by goniometer).
Time Frame
6 months
Title
Complications and/or adverse effects.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikel Sanchez
Organizational Affiliation
UCA (Unidad de Cirugía Artroscópica Mikel Sanchez). USP Clínica la Esperanza. C/LA Esperanza 3, 01002 Vitoria (Alava)SPAIN.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jaime Usabiaga
Organizational Affiliation
Hospital Donostia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Javier Albillos
Organizational Affiliation
Policlinica Gipuzkoa
Official's Role
Study Director
Facility Information:
Facility Name
UCA (Unidad de Cirugía Artroscopica Mikel Sanchez.) Clinica USP La Esperanza.
City
Vitoria
State/Province
Alava
Country
Spain
Facility Name
Hospital Donostia.
City
San Sebastian
State/Province
Gipuzkoa
Country
Spain
Facility Name
Policlinica Gipuzkoa
City
San Sebastian
State/Province
Gipuzkoa
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://www.prgf.net
Description
Related Info
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Autologous Plasma Rich in Growth Factors (PRGF) Treating the Symptomatic Knee OA
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