Treatment of ATFL Tears With PRP

Soft Tissue Healing Clinical Trial

Official title:

Treatment of ATFL Tears After Ankle Sprains With PRP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725907
• Other study ID #: 6000
• Secondary ID: MeirMc07om0091CT
• Status: Completed
• Phase: N/A
• First received: July 29, 2008
• Last updated: July 10, 2011
• Start date: January 2008
• Est. completion date: January 2009

Study information

• Verified date: July 2011
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

PRP will enhance ATFL tears healing by time and quality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Soft Tissue Healing

Intervention

Biological:
• PGRF
injection of 6cc into injured area
• placebo saline
injection of 6cc into injured area

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to return to active sport		2	No