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

A Double-Blind, Randomized, Placebo Controlled Study Evaluating the Use of Platelet Rich Plasma Therapy for Acute Ankle Sprains in the Emergency Department.

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.

Study Overview

• Status: Completed
• Conditions: Sprain of Ankle
• Intervention / Treatment: Procedure: Platelet rich plasma injection; Procedure: Placebo Comparator: Placebo/Standard of Care

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Einstein Healthcare Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• severe ankle sprain
• X-ray completed

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet Rich Plasma; Patients receive Platelet rich plasma injection + standard of care therapy(bandaging or boot and crutches) + non-NSAID pain medicine	Procedure: Platelet rich plasma injection; 50ml of blood drawn into a 60cc with 10cc of anticoagulant is processed using MAGELLAN® Autologous Platelet (Arteriocyte Medical Systems, Cleveland Ohio)to separate out approximately 3-6 cc of platelet rich plasma, which is mixed with 1 cc of 1 % Lidocaine (xylocaine) and 1 cc of 0.25 % Marcaine (bupivacaine) and injected into the site of injury under USG guidance.
Placebo Comparator: Placebo/Standard of Care; Patient receives Placebo Comparator: Placebo/Standard of Care [saline injection + standard of care (bandaging or boot and crutches)] + non-NSAID pain medicine	Procedure: Placebo Comparator: Placebo/Standard of Care; 50ml of blood is drawn into a 60cc with 10cc of anticoagulant and is then discarded. 4 cc of saline solution is mixed with 1 cc of 1 % Lidocaine (xylocaine) and 1 cc of 0.25 % Marcaine (bupivacaine) and injected into the site of injury under USG guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of LEFS score, a previous validated 80-point scale used to quantify lower extremity function.	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.	Day 0; Day2-3; Day 8-10; Day30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain from baseline	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.	Day 0; Day 2-3, Day 8-10, Day 30

Collaborators and Investigators

• Sponsor: Albert Einstein Healthcare Network
• Investigators: Principal Investigator: Adam Rowden, DO, Eisntein Healthcare Network

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: December 8, 2011
• First Submitted That Met QC Criteria: January 23, 2012
• First Posted (Estimate): January 26, 2012

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: ankle; platelet rich plasma; sprain; injection; Platelet Rich Plasma therapy; focal, invasive therapy for sprains
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Disease Attributes; Emergencies; Sprains and Strains; Ankle Injuries
• Other Study ID Numbers: HN4157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No