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

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
PRGF
hyaluronic acid
placebo
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Meir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Improvment of symptomes

Secondary Outcome Measures

Full Information

First Posted
August 3, 2008
Last Updated
July 10, 2011
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00728611
Brief Title
Preparation Rich in Growth Factors (PRGF) Treatment for Osteoarthritis of the Knee
Official Title
PRP as a Treatment for Knee Osteoarthritis - Randomized-double-blind-placebo Control Trail.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Meir Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
PRGF
Other Intervention Name(s)
platelet-derived preparation rich in growth factors
Intervention Description
intra auricular injection 6mg
Intervention Type
Drug
Intervention Name(s)
hyaluronic acid
Other Intervention Name(s)
Arthrease
Intervention Description
20 mg / 2 ml
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
seline 0.9% nacl
Intervention Description
physiological water 3cc + lidocain 3cc
Primary Outcome Measure Information:
Title
Improvment of symptomes
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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