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

July 10, 2011 updated by: Meir Medical Center

PRP as a Treatment for Knee Osteoarthritis - Randomized-double-blind-placebo Control Trail.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Biological: PRGF
intra auricular injection 6mg
Other Names:
  • platelet-derived preparation rich in growth factors
Active Comparator: 2
Drug: hyaluronic acid
20 mg / 2 ml
Other Names:
  • Arthrease
Placebo Comparator: 3
Drug: placebo
physiological water 3cc + lidocain 3cc
Other Names:
  • seline 0.9% nacl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvment of symptomes
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

August 3, 2008

First Submitted That Met QC Criteria

August 5, 2008

First Posted (Estimate)

August 6, 2008

Study Record Updates

Last Update Posted (Estimate)

July 12, 2011

Last Update Submitted That Met QC Criteria

July 10, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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