NCT00728611

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

July 12, 2011

Status Verified

July 1, 2011

Enrollment Period

1.1 years

First QC Date

August 3, 2008

Last Update Submit

July 10, 2011

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

  • Improvment of symptomes

    1 year

Study Arms (3)

1

EXPERIMENTAL
Biological: PRGF

2

ACTIVE COMPARATOR
Drug: hyaluronic acid

3

PLACEBO COMPARATOR
Drug: placebo

Interventions

PRGFBIOLOGICAL

intra auricular injection 6mg

Also known as: platelet-derived preparation rich in growth factors
1
hyaluronic acidDRUG

20 mg / 2 ml

Also known as: Arthrease
2
placeboDRUG

physiological water 3cc + lidocain 3cc

Also known as: seline 0.9% nacl
3

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, Knee

Interventions

Intercellular Signaling Peptides and ProteinsHyaluronic AcidSodium Chloride

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsGlycosaminoglycansPolysaccharidesCarbohydratesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

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

August 3, 2008

First Posted

August 6, 2008

Study Start

January 1, 2008

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

July 12, 2011

Record last verified: 2011-07

Locations

IL(1)