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

This study has been withdrawn prior to enrollment.
Information provided by:
Meir Medical Center Identifier:
First received: August 28, 2008
Last updated: July 10, 2011
Last verified: July 2011
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of PRGF on Healing of MCL Tear - Randomized-Double-Blind-Placebo Control Trail

Resource links provided by NLM:

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • time and efficiency of healing [ Time Frame: 1 year ]

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
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.

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00743886

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

Responsible Party: Omer Mei-Dan, Meir Medical Center Identifier: NCT00743886     History of Changes
Other Study ID Numbers: 5000
Study First Received: August 28, 2008
Last Updated: July 10, 2011

Additional relevant MeSH terms:
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017