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

Overview[ - collapse ][ - ]

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.
ConditionOsteoarthritis of the Knee
InterventionBiological: Platelet Rich Plasma (Preparation Rich in Growth Factors)
Drug: Hyaluronic acid
PhasePhase 2/Phase 3
SponsorMeir Medical Center
Responsible PartyMeir Medical Center
ClinicalTrials.gov IdentifierNCT01270412
First ReceivedDecember 20, 2010
Last UpdatedJuly 16, 2011
Last verifiedJuly 2011

Tracking Information[ + expand ][ + ]

First Received DateDecember 20, 2010
Last Updated DateJuly 16, 2011
Start DateSeptember 2011
Estimated Primary Completion DateDecember 2013
Current Primary Outcome MeasuresImprovement 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.
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitlePlatelet Rich Plasma (PRP) as a Treatment for Knee Osteoarthritis PRP as a Treatment for Knee Osteoarthritis
Official TitlePlatelet Rich Plasma (PRP) as a Treatment for Knee Osteoarthritis - A Randomized-Double-Blind Trial
Brief Summary
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
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.
Study TypeInterventional
Study PhasePhase 2/Phase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
ConditionOsteoarthritis of the Knee
InterventionBiological: Platelet Rich Plasma (Preparation Rich in Growth Factors)
intra articular injection 6ml
Other Names:
Platelet-derived preparation rich in growth factorsDrug: Hyaluronic acid
Intra articular injections: 20 mg / 2 ml
Other Names:
"Arthrease"
Study Arm (s)
  • Experimental: Platelet Rich Plasma (Preparation Rich in Growth Factors)
    intra articular injection 6ml of platelet-derived preparation rich in growth factors
  • Active Comparator: Hyaluronic acid
    Drug: hyaluronic acid 20 mg / 2 ml Other Name: Arthrease

Recruitment Information[ + expand ][ + ]

Recruitment StatusNot yet recruiting
Estimated Enrollment100
Estimated Completion DateDecember 2013
Estimated Primary Completion DateDecember 2012
Eligibility 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
GenderBoth
Ages40 Years
Accepts Healthy VolunteersNo
ContactsContact: Lior Laver, MD
+972-50-8464466
laver17@gmail.com
Location CountriesIsrael

Administrative Information[ + expand ][ + ]

NCT Number NCT01270412
Other Study ID NumbersMMC10196-2010CTIL
Has Data Monitoring CommitteeNo
Information Provided ByMeir Medical Center
Study SponsorMeir Medical Center
CollaboratorsNot Provided
Investigators Principal Investigator: Lior Laver, MD Meir Medical Center
Verification DateJuly 2011

Locations[ + expand ][ + ]

Meir Medical Center
Kfar-Saba, Israel
Sub-Investigator: Yaron Brin, MD
Not yet recruiting