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NCT00728611 Clinical Trial

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

Osteoarthritis of the Knee Clinical Trial

Official title:
PRP as a Treatment for Knee Osteoarthritis - Randomized-double-blind-placebo Control Trail.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00728611
Other study ID # 1000
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received August 3, 2008
Last updated July 10, 2011
Start date January 2008
Est. completion date March 2009

Study information
Verified date July 2011
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date March 2009
Est. primary completion date February 2009
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

Intervention

Biological:
• PRGF
intra auricular injection 6mg
Drug:
• hyaluronic acid
20 mg / 2 ml
• placebo
physiological water 3cc + lidocain 3cc

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 Improvment of symptomes 1 year Yes
See also
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Recruiting NCT03090698 - Outcomes of Injections in Patients Waiting for Total Knee Replacement Phase 4
Completed NCT02556710 - A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee Phase 3
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Completed NCT02242435 - A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis Phase 3
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Completed NCT01410409 - Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement N/A
Not yet recruiting NCT01270412 - Platelet Rich Plasma (PRP) as a Treatment for Knee Osteoarthritis PRP as a Treatment for Knee Osteoarthritis Phase 2/Phase 3
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Completed NCT00988091 - Investigation of 1.2% Sodium Hyaluronate for Treatment of Painful Chronic Osteoarthritis of the Knee Phase 3
Completed NCT00531427 - Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee Phase 3
Completed NCT00792727 - HKT-500 in Adult Patients With Osteoarthritis (OA) Knee Pain Phase 3
Completed NCT00449696 - Gel-200 Versus Placebo in Osteoarthritis of the Knee Phase 3
Completed NCT04145011 - Coolief Cooled Radiofrequency vs. Conventional Radiofrequency to Manage OA Knee Pain N/A