Treatment of ATFL Tears With PRP

NCT ID: NCT00725907

Last Updated: 2011-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-01-31

Brief Summary

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PRP will enhance ATFL tears healing by time and quality.

Detailed Description

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Conditions

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Soft Tissue Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

PGRF

Group Type EXPERIMENTAL

PGRF

Intervention Type BIOLOGICAL

injection of 6cc into injured area

2

saline

Group Type PLACEBO_COMPARATOR

placebo saline

Intervention Type BIOLOGICAL

injection of 6cc into injured area

Interventions

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PGRF

injection of 6cc into injured area

Intervention Type BIOLOGICAL

placebo saline

injection of 6cc into injured area

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* athletes 18-30 years old 1st sprain within 3 days from injury
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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"Meir" Medical Center, Kfar Saba, Israel

Principal Investigators

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omer mei-dan, MD

Role: STUDY_DIRECTOR

Meir Medical Center

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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MeirMc07om0091CTIL

Identifier Type: -

Identifier Source: secondary_id

6000

Identifier Type: -

Identifier Source: org_study_id

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