NCT00743886

Brief Summary

To evaluate the influence of Plasma Rich in Growth Factors (PRGF) on the healing process of medial collateral ligament (MCL) tear.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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
8 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2008

Completed
5 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 28, 2008

Last Update Submit

July 10, 2011

Conditions

MCL Tear

Outcome Measures

Primary Outcomes (1)

  • time and efficiency of healing

    1 year

Study Arms (2)

2

PLACEBO COMPARATOR

saline

Drug: saline

1

EXPERIMENTAL

Plasma Rich in Growth Factors (PRGF)

Biological: Plasma Rich in Growth Factors (PRGF)

Interventions

Plasma Rich in Growth Factors (PRGF)BIOLOGICAL

injection onto injured area in ligament dose: 3-6mg

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

injection of 6 cc of saline into injured area

Also known as: saline 0.9% NaCl
2

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-40 years old
  • diagnosed MCL tear grade 2/3

You may not qualify if:

  • pregnancy
  • mental or physical disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Interventions

Intercellular Signaling Peptides and ProteinsSodium Chloride

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Omer Mei Dan, Dr

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

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 28, 2008

First Posted

August 29, 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)