Platelet Rich Plasma (PRP) as a Treatment for Knee Osteoarthritis PRP as a Treatment for Knee Osteoarthritis

NCT ID: NCT01270412

Last Updated: 2011-07-19

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

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-12-31

Brief Summary

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Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in osteoarthritis (OA) capsular joints via multiple mechanisms. The aim is to examine the effect of a platelet-derived preparation rich in growth factors (PRGFs) in OA of the 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. The investigators aim is to examine the effect of a platelet-derived preparation rich in growth factors(PRGFs) in OA of the knee, using parameters of pain, function, quality of life and safety.

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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Platelet Rich Plasma (Preparation Rich in Growth Factors)

intra articular injection 6ml of platelet-derived preparation rich in growth factors

Group Type EXPERIMENTAL

Platelet Rich Plasma (Preparation Rich in Growth Factors)

Intervention Type BIOLOGICAL

intra articular injection 6ml

Hyaluronic acid

Drug: hyaluronic acid 20 mg / 2 ml Other Name: Arthrease

Group Type ACTIVE_COMPARATOR

Platelet Rich Plasma (Preparation Rich in Growth Factors)

Intervention Type BIOLOGICAL

intra articular injection 6ml

Hyaluronic acid

Intervention Type DRUG

Intra articular injections: 20 mg / 2 ml

Interventions

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Platelet Rich Plasma (Preparation Rich in Growth Factors)

intra articular injection 6ml

Intervention Type BIOLOGICAL

Hyaluronic acid

Intra articular injections: 20 mg / 2 ml

Intervention Type DRUG

Other Intervention Names

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Platelet-derived preparation rich in growth factors "Arthrease"

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

Principal Investigators

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Lior Laver, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Central Contacts

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Lior Laver, MD

Role: CONTACT

+972-50-8464466

Other Identifiers

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MMC10196-2010CTIL

Identifier Type: -

Identifier Source: org_study_id

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