Preparation Rich in Growth Factors (PRGF) Treatment for Osteoarthritis of the Knee

NCT ID: NCT00728611

Last Updated: 2011-07-12

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

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-03-31

Brief Summary

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to evaluate the influence of PRGF treatment on patient suffering from OA knee

Detailed Description

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Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in osteoarthritis (OA) capsular joints via multiple mechanisms. Our aim is to examine the effect of a platelet-derived preparation rich in growth factors (PRGFs) in OA knee

Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

PRGF

Intervention Type BIOLOGICAL

intra auricular injection 6mg

2

Group Type ACTIVE_COMPARATOR

hyaluronic acid

Intervention Type DRUG

20 mg / 2 ml

3

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

physiological water 3cc + lidocain 3cc

Interventions

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PRGF

intra auricular injection 6mg

Intervention Type BIOLOGICAL

hyaluronic acid

20 mg / 2 ml

Intervention Type DRUG

placebo

physiological water 3cc + lidocain 3cc

Intervention Type DRUG

Other Intervention Names

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platelet-derived preparation rich in growth factors Arthrease seline 0.9% nacl

Eligibility Criteria

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Inclusion Criteria

* age 40-75 years old
* diagnosed Oa of the knee more then 1 year
* no knee deformation

Exclusion Criteria

* mental of physical disabilities
* pregnancy
* deformities of the knee
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Meir Medical Center

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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1000

Identifier Type: -

Identifier Source: org_study_id

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