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

NCT ID: NCT00782197

Last Updated: 2010-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Joint Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

PRGF

Group Type EXPERIMENTAL

PRGF Intraarticular injection

Intervention Type DEVICE

Three consecutive PRGF injections each one week apart.

2

Hyaluronic Acid

Group Type ACTIVE_COMPARATOR

Hyaluronic Acid Intraarticular injection

Intervention Type DEVICE

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

Interventions

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PRGF Intraarticular injection

Three consecutive PRGF injections each one week apart.

Intervention Type DEVICE

Hyaluronic Acid Intraarticular injection

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotechnology Institute IMASD

INDUSTRY

Sponsor Role lead

Principal Investigators

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Mikel Sanchez

Role: PRINCIPAL_INVESTIGATOR

UCA (Unidad de Cirugía Artroscópica Mikel Sanchez). USP Clínica la Esperanza. C/LA Esperanza 3, 01002 Vitoria (Alava)SPAIN.

Jaime Usabiaga

Role: STUDY_DIRECTOR

Hospital Donostia

Javier Albillos

Role: STUDY_DIRECTOR

Policlinica Gipuzkoa

Locations

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

Vitoria-Gasteiz, Alava, Spain

Site Status

Hospital Donostia.

Donostia / San Sebastian, Gipuzkoa, Spain

Site Status

Policlinica Gipuzkoa

Donostia / San Sebastian, Gipuzkoa, Spain

Site Status

Countries

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Spain

Related Links

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http://www.prgf.net

Related Info

Other Identifiers

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BTI-01-EC/07/ART

Identifier Type: -

Identifier Source: org_study_id