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

This study has been completed.
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00728611
First received: August 3, 2008
Last updated: July 10, 2011
Last verified: July 2011
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PRP as a Treatment for Knee Osteoarthritis - Randomized-double-blind-placebo Control Trail.

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Improvment of symptomes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728611

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

No publications provided

Responsible Party: Omer Mei Dan, Meir Medical Center
ClinicalTrials.gov Identifier: NCT00728611     History of Changes
Other Study ID Numbers: 1000
Study First Received: August 3, 2008
Last Updated: July 10, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on October 21, 2014