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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014