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
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 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 September 18, 2014