NCT01270412

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 5, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 19, 2011

Status Verified

July 1, 2011

Enrollment Period

1.3 years

First QC Date

December 20, 2010

Last Update Submit

July 16, 2011

Conditions

Osteoarthritis of the Knee

Keywords

OsteoarthritisPRPPRGFHyaluronic acid

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Platelet Rich Plasma (Preparation Rich in Growth Factors)

EXPERIMENTAL

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

Biological: Platelet Rich Plasma (Preparation Rich in Growth Factors)

Hyaluronic acid

ACTIVE COMPARATOR

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

Biological: Platelet Rich Plasma (Preparation Rich in Growth Factors)Drug: Hyaluronic acid

Interventions

Platelet Rich Plasma (Preparation Rich in Growth Factors)BIOLOGICAL

intra articular injection 6ml

Also known as: Platelet-derived preparation rich in growth factors
Hyaluronic acidPlatelet Rich Plasma (Preparation Rich in Growth Factors)
Hyaluronic acidDRUG

Intra articular injections: 20 mg / 2 ml

Also known as: "Arthrease"
Hyaluronic acid

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 40-75 years old
  • diagnosed Oa of the knee more then 1 year
  • no knee deformation

You may not qualify if:

  • mental of physical disabilities
  • pregnancy
  • deformities of the knee

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Intercellular Signaling Peptides and ProteinsHyaluronic Acid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Lior Laver, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lior Laver, MD

CONTACT

+972-50-8464466laver17@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2010

First Posted

January 5, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

July 19, 2011

Record last verified: 2011-07

Locations

IL(1)