Use of Platelet Rich Plasma Therapy for Acute Ankle Sprains in the Emergency Department

Not Applicable

Completed

• Conditions: Sprain of Ankle
• Interventions: Procedure: Platelet rich plasma injection

• Registration Number: NCT01518335
• Lead Sponsor: Albert Einstein Healthcare Network

Brief Summary

This research study hopes to determine whether or not platelet rich plasma therapy improves healing time of moderate to severe ankle sprain in comparison to standard of care therapy.

Detailed Description

The intention of this research project is to study a new treatment for severe ankle sprains.This new treatment is called Platelet Rich Plasma (PRP) therapy and involves injecting concentrated platelet's from a patient's own blood into the site of injury to aid healing. Platelets, aside from their clotting capabilities also serve a role in re-vascularization of tissue as well as collagen repair. PRP therapy has been used in sports medicine for treatment of chronic injuries but has yet to be proven effective in acute injury of a joint. The investigators are comparing treatment and placebo groups based on a subjective patient questionnaire and pain score administered on the day of injury and 2-3 days and 8-10 days follow up.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2011-12-08
• Primary Completion: 2012-01
• Study First Submitted QC: 2012-01-23
• Study First Posted: 2012-01-26
• Study Completion: 2012-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• severe ankle sprain
• X-ray completed

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Exclusion Criteria

• Pregnancy/breastfeeding
• Police custody
• active infection
• metastatic disease/tumors
• History of thrombocytopenia
• Allergy to ester or amine anesthetics
• On anticoagulant medication
• Peripheral vascular disease
• Known coagulopathy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet Rich Plasma	Platelet rich plasma injection	Patients receive Platelet rich plasma injection + standard of care therapy(bandaging or boot and crutches) + non-NSAID pain medicine

Primary Outcome Measures

Name	Time	Method
Change from baseline of LEFS score, a previous validated 80-point scale used to quantify lower extremity function.	Day 0; Day2-3; Day 8-10; Day30	The primary outcome of this investigation is change from baseline in LEFS score, a previous validated 80-point scale used to quantify lower extremity function. A difference of 9 points is considered clinically significant.

Secondary Outcome Measures

Name	Time	Method
Change in pain from baseline	Day 0; Day 2-3, Day 8-10, Day 30	Changes in level of pain from baseline was measured using VAS scale as well as comparing need for narcotics use at each follow up time point.

Trial Locations

Locations (1)

Einstein Healthcare Network; 🇺🇸 Philadelphia, Pennsylvania, United States