Influence of Plasma Rich in Growth Factors (PRGF) on Healing of Medial Collateral Ligament (MCL) Tear

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00743886
First received: August 28, 2008
Last updated: July 10, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
MCL Tear
Biological: Plasma Rich in Growth Factors (PRGF)
Drug: saline
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of PRGF on Healing of MCL Tear - Randomized-Double-Blind-Placebo Control Trail

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • time and efficiency of healing [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
saline
Drug: saline
injection of 6 cc of saline into injured area
Other Name: saline 0.9% NaCl
Experimental: 1
Plasma Rich in Growth Factors (PRGF)
Biological: Plasma Rich in Growth Factors (PRGF)
injection onto injured area in ligament dose: 3-6mg
Other Name: platelet-derived preparation rich in growth factors

Detailed Description:

Autologous platelet-rich matrices may aid in the healing of ligaments & tendons by promoting and accelerating tissue healing because of the release of growth factors including transforming growth factor (TGF)-beta1 and platelet-derived growth factor (PDGF) from platelet alpha-granules.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • mental or physical disabilities
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743886

Locations
Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Omer Mei Dan, Dr Meir Medical Center
  More Information

No publications provided

Responsible Party: Omer Mei-Dan, Meir Medical Center
ClinicalTrials.gov Identifier: NCT00743886     History of Changes
Other Study ID Numbers: 5000
Study First Received: August 28, 2008
Last Updated: July 10, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014