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

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ClinicalTrials.gov Identifier: NCT00743886
Recruitment Status : Withdrawn
First Posted : August 29, 2008
Last Update Posted : July 12, 2011
Sponsor:
Information provided by:
Meir Medical Center

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

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Study Start Date : January 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
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




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


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Omer Mei-Dan, Meir Medical Center
ClinicalTrials.gov Identifier: NCT00743886     History of Changes
Other Study ID Numbers: 5000
First Posted: August 29, 2008    Key Record Dates
Last Update Posted: July 12, 2011
Last Verified: July 2011

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