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

Primary Purpose

Osteoarthritis of the Knee

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Platelet Rich Plasma (Preparation Rich in Growth Factors)

Hyaluronic acid

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis, PRP, PRGF, Hyaluronic acid

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 Type

Experimental

Active Comparator

Arm Label

Platelet Rich Plasma (Preparation Rich in Growth Factors)

Hyaluronic acid

Arm Description

intra articular injection 6ml of platelet-derived preparation rich in growth factors

Drug: hyaluronic acid 20 mg / 2 ml Other Name: Arthrease

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01270412

First Posted

December 20, 2010

Last Updated

July 16, 2011

Sponsor

Meir Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01270412

Brief Title

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

Acronym

PRP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Meir Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

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

Osteoarthritis of the Knee

Keywords

Osteoarthritis, PRP, PRGF, Hyaluronic acid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Platelet Rich Plasma (Preparation Rich in Growth Factors)

Arm Type

Experimental

Arm Description

intra articular injection 6ml of platelet-derived preparation rich in growth factors

Arm Title

Hyaluronic acid

Arm Type

Active Comparator

Arm Description

Drug: hyaluronic acid 20 mg / 2 ml Other Name: Arthrease

Intervention Type

Biological

Intervention Name(s)

Platelet Rich Plasma (Preparation Rich in Growth Factors)

Other Intervention Name(s)

Platelet-derived preparation rich in growth factors

Intervention Description

intra articular injection 6ml

Intervention Type

Drug

Intervention Name(s)

Hyaluronic acid

Other Intervention Name(s)

"Arthrease"

Intervention Description

Intra articular injections: 20 mg / 2 ml

Primary Outcome Measure Information:

Title

Improvement in pain, function, quality of life and activity level in knee osteoarthritis

Description

Improvement in pain, function, quality of life, activity level - using scores adapted to measure these parameters in knee osteoarthritis.

Time Frame

1 -2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lior Laver, MD

Phone

+972-50-8464466

laver17@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lior Laver, MD

Organizational Affiliation

Meir Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Meir Medical Center

City

Kfar-Saba

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yaron Brin, MD

First Name & Middle Initial & Last Name & Degree

Guy Maoz, MD

First Name & Middle Initial & Last Name & Degree

Eyal Yaacobi, MD

First Name & Middle Initial & Last Name & Degree

Eran Dolev, MD

First Name & Middle Initial & Last Name & Degree

Ziv Heller, MD

First Name & Middle Initial & Last Name & Degree

Asaf Bivas, MD

First Name & Middle Initial & Last Name & Degree

Meir Nyska, MD

12. IPD Sharing Statement

Learn more about this trial

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

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