Preparation Rich in Growth Factors (PRGF) Treatment for Osteoarthritis of the Knee - Full Text View

Purpose

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

Condition	Intervention	Phase
Osteoarthritis of the Knee	Biological: PRGF Drug: hyaluronic acid Drug: placebo	Phase II Phase III

MedlinePlus related topics:

Osteoarthritis

ChemIDplus related topics:

Hyaluronate Sodium Hyaluronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	PRP as a Treatment for Knee Osteoarthritis - Randomized-Double-Blind-Placebo Control Trail.

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:

Improvment of symptomes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	January 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: PRGF intra auricular injection 6mg
2: Active Comparator	Drug: hyaluronic acid 20 mg / 2 ml
3: Placebo Comparator	Drug: placebo physiological water 3cc + lidocain 3cc

Detailed 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

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: NCT00728611

Contacts


Contact: Omer Mei Dan, dr		OMER.MEI-DAN@CLALIT.ORG.IL

Locations


Israel
	Meir Medical Center	Recruiting
	Kfar Saba, Israel
	Contact: Mei Dan, dr OMER.MEI-DAN@CLALIT.ORG.IL
	Principal Investigator: Omer Mei Dan, dr
	Principal Investigator: Avi Shtern, dr
	Sub-Investigator: Gay Maoz, dr
	Sub-Investigator: Iftach Chetzroni, dr

Sponsors and Collaborators

Meir Medical Center

More Information

Responsible Party:	Meir Medical Center ( Omer Mei Dan )
Study ID Numbers:	1000
First Received:	August 3, 2008
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00728611
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Study placed in the following topic categories:

Osteoarthritis, Knee

Musculoskeletal Diseases

Hyaluronic Acid

Osteoarthritis

Joint Diseases

Arthritis

Rheumatic Diseases

Additional relevant MeSH terms:

Immunologic Factors

Physiological Effects of Drugs

Adjuvants, Immunologic

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008

Sponsored by:	Meir Medical Center
Information provided by:	Meir Medical Center
ClinicalTrials.gov Identifier:	NCT00728611