- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00725907
Treatment of ATFL Tears With PRP
July 10, 2011 updated by: Meir Medical Center
Treatment of ATFL Tears After Ankle Sprains With PRP
PRP will enhance ATFL tears healing by time and quality.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kfar Saba, Israel
- Meir Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- athletes 18-30 years old 1st sprain within 3 days from injury
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
saline
|
injection of 6cc into injured area
|
Experimental: 1
PGRF
|
injection of 6cc into injured area
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
time to return to active sport
Time Frame: 2
|
2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: omer mei-dan, MD, Meir Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
July 29, 2008
First Submitted That Met QC Criteria
July 30, 2008
First Posted (Estimate)
July 31, 2008
Study Record Updates
Last Update Posted (Estimate)
July 12, 2011
Last Update Submitted That Met QC Criteria
July 10, 2011
Last Verified
July 1, 2011
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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