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

Osteoarthritis of the Knee Clinical Trial

— PRP  

Official title:

Platelet Rich Plasma (PRP) as a Treatment for Knee Osteoarthritis - A Randomized-Double-Blind Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01270412
• Other study ID #: MMC10196-2010CTIL
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: December 20, 2010
• Last updated: July 16, 2011
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: July 2011
• Source: Meir Medical Center
• Contact: Lior Laver, MD
• Phone: +972-50-8464466
• Email: laver17[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Biological:
• Platelet Rich Plasma (Preparation Rich in Growth Factors)
intra articular injection 6ml

Drug:
• Hyaluronic acid
Intra articular injections: 20 mg / 2 ml

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar-Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in pain, function, quality of life and activity level in knee osteoarthritis	Improvement in pain, function, quality of life, activity level - using scores adapted to measure these parameters in knee osteoarthritis.	1 -2 years	No