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

This study is not yet open for participant recruitment.
Verified July 2011 by Meir Medical Center
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01270412
First received: December 20, 2010
Last updated: July 16, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Osteoarthritis of the Knee
 Biological: Platelet Rich Plasma (Preparation Rich in Growth Factors)
Drug: Hyaluronic acid
 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: Platelet Rich Plasma (PRP) as a Treatment for Knee Osteoarthritis - A Randomized-Double-Blind Trial

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Improvement in pain, function, quality of life and activity level in knee osteoarthritis [ Time Frame: 1 -2 years ] [ Designated as safety issue: No ]
    Improvement in pain, function, quality of life, activity level - using scores adapted to measure these parameters in knee osteoarthritis.


Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Platelet Rich Plasma (Preparation Rich in Growth Factors)
intra articular injection 6ml of platelet-derived preparation rich in growth factors
 Biological: Platelet Rich Plasma (Preparation Rich in Growth Factors)
intra articular injection 6ml
Other Name: Platelet-derived preparation rich in growth factors
Active Comparator: Hyaluronic acid
Drug: hyaluronic acid 20 mg / 2 ml Other Name: Arthrease
 Biological: Platelet Rich Plasma (Preparation Rich in Growth Factors)
intra articular injection 6ml
Other Name: Platelet-derived preparation rich in growth factors
Drug: Hyaluronic acid
Intra articular injections: 20 mg / 2 ml
Other Name: "Arthrease"

Detailed Description:

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.

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270412

Contacts
Contact: Lior Laver, MD +972-50-8464466 laver17@gmail.com

Locations
Israel
Meir Medical Center Not yet recruiting
Kfar-Saba, Israel
Sub-Investigator: Yaron Brin, MD            
Sub-Investigator: Guy Maoz, MD            
Sub-Investigator: Eyal Yaacobi, MD            
Sub-Investigator: Eran Dolev, MD            
Sub-Investigator: Ziv Heller, MD            
Sub-Investigator: Asaf Bivas, MD            
Sub-Investigator: Meir Nyska, MD            
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Lior Laver, MD Meir Medical Center
  More Information

No publications provided

Responsible Party: Dr. Lior Laver, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01270412     History of Changes
Other Study ID Numbers: MMC10196-2010CTIL
Study First Received: December 20, 2010
Last Updated: July 16, 2011
Health Authority: Israel: Clalit Health Services

Keywords provided by Meir Medical Center:
Osteoarthritis
PRP
PRGF
Hyaluronic acid

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

ClinicalTrials.gov processed this record on May 21, 2013