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Treatment of ATFL Tears With PRP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00725907
Recruitment Status : Completed
First Posted : July 31, 2008
Last Update Posted : July 12, 2011
Information provided by:
Meir Medical Center

Brief Summary:
PRP will enhance ATFL tears healing by time and quality.

Condition or disease Intervention/treatment
Soft Tissue Healing Biological: PGRF Biological: placebo saline

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of ATFL Tears After Ankle Sprains With PRP
Study Start Date : January 2008
Primary Completion Date : December 2008
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Biological: PGRF
injection of 6cc into injured area
Placebo Comparator: 2
Biological: placebo saline
injection of 6cc into injured area

Primary Outcome Measures :
  1. time to return to active sport [ Time Frame: 2 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • athletes 18-30 years old 1st sprain within 3 days from injury

Exclusion Criteria:

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): NCT00725907

Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Study Director: omer mei-dan, MD Meir Medical Center

Responsible Party: "Meir" Medical Center, Kfar Saba, Israel
ClinicalTrials.gov Identifier: NCT00725907     History of Changes
Other Study ID Numbers: 6000
First Posted: July 31, 2008    Key Record Dates
Last Update Posted: July 12, 2011
Last Verified: July 2011

Keywords provided by Meir Medical Center: