Treatment of ATFL Tears With PRP

This study has been completed.
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00725907
First received: July 29, 2008
Last updated: July 10, 2011
Last verified: July 2011
  Purpose

PRP will enhance ATFL tears healing by time and quality.


Condition Intervention
Soft Tissue Healing
Biological: PGRF
Biological: placebo saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of ATFL Tears After Ankle Sprains With PRP

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • time to return to active sport [ Time Frame: 2 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2008
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
PGRF
Biological: PGRF
injection of 6cc into injured area
Placebo Comparator: 2
saline
Biological: placebo saline
injection of 6cc into injured area

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725907

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

No publications provided

Responsible Party: "Meir" Medical Center, Kfar Saba, Israel
ClinicalTrials.gov Identifier: NCT00725907     History of Changes
Other Study ID Numbers: 6000, MeirMc07om0091CTIL
Study First Received: July 29, 2008
Last Updated: July 10, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Meir Medical Center:
PRP
ATFL

ClinicalTrials.gov processed this record on April 20, 2014