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

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ClinicalTrials.gov Identifier: NCT00728611
Recruitment Status : Completed
First Posted : August 6, 2008
Last Update Posted : July 12, 2011
Sponsor:
Information provided by:
Meir Medical Center

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

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Biological: PRGF Drug: hyaluronic acid Drug: placebo Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PRP as a Treatment for Knee Osteoarthritis - Randomized-double-blind-placebo Control Trail.
Study Start Date : January 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Improvment of symptomes [ Time Frame: 1 year ]


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728611


Locations
Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center

Responsible Party: Omer Mei Dan, Meir Medical Center
ClinicalTrials.gov Identifier: NCT00728611     History of Changes
Other Study ID Numbers: 1000
First Posted: August 6, 2008    Key Record Dates
Last Update Posted: July 12, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Mitogens
Hyaluronic Acid
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents