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. |
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Condition | Osteoarthritis of the Knee |
Intervention | Biological: Platelet Rich Plasma (Preparation Rich in Growth Factors) Drug: Hyaluronic acid |
Phase | Phase 2/Phase 3 |
Sponsor | Meir Medical Center |
Responsible Party | Meir Medical Center |
ClinicalTrials.gov Identifier | NCT01270412 |
First Received | December 20, 2010 |
Last Updated | July 16, 2011 |
Last verified | July 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | December 20, 2010 |
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Last Updated Date | July 16, 2011 |
Start Date | September 2011 |
Estimated Primary Completion Date | December 2013 |
Current 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. |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Platelet Rich Plasma (PRP) as a Treatment for Knee Osteoarthritis PRP as a Treatment for Knee Osteoarthritis |
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Official Title | Platelet 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 Type | Interventional |
Study Phase | Phase 2/Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Osteoarthritis of the Knee |
Intervention | Biological: 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) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Not yet recruiting |
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Estimated Enrollment | 100 |
Estimated Completion Date | December 2013 |
Estimated Primary Completion Date | December 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 |
Gender | Both |
Ages | 40 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Lior Laver, MD +972-50-8464466 laver17@gmail.com |
Location Countries | Israel |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01270412 |
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Other Study ID Numbers | MMC10196-2010CTIL |
Has Data Monitoring Committee | No |
Information Provided By | Meir Medical Center |
Study Sponsor | Meir Medical Center |
Collaborators | Not Provided |
Investigators | Principal Investigator: Lior Laver, MD Meir Medical Center |
Verification Date | July 2011 |
Locations[ + expand ][ + ]
Meir Medical Center | Kfar-Saba, Israel Sub-Investigator: Yaron Brin, MDNot yet recruiting |
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