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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01518335
First Posted: January 26, 2012
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
James Gardner, MD, Albert Einstein Healthcare Network
  Purpose
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.

Condition Intervention
Sprain of Ankle Procedure: Platelet rich plasma injection Procedure: Placebo Comparator: Placebo/Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo Controlled Study Evaluating the Use of Platelet Rich Plasma Therapy for Acute Ankle Sprains in the Emergency Department.

Further study details as provided by James Gardner, MD, Albert Einstein Healthcare Network:

Primary Outcome Measures:
  • Change from baseline of LEFS score, a previous validated 80-point scale used to quantify lower extremity function. [ Time Frame: 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:
  • Change in pain from baseline [ Time Frame: 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.


Enrollment: 38
Study Start Date: June 2009
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01518335


Locations
United States, Pennsylvania
Einstein Healthcare Network
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
Albert Einstein Healthcare Network
Investigators
Principal Investigator: Adam Rowden, DO Eisntein Healthcare Network
  More Information

Responsible Party: James Gardner, MD, MD, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT01518335     History of Changes
Other Study ID Numbers: HN4157
First Submitted: December 8, 2011
First Posted: January 26, 2012
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by James Gardner, MD, Albert Einstein Healthcare Network:
platelet rich plasma
ankle
sprain
injection
Platelet Rich Plasma therapy
focal, invasive therapy for sprains

Additional relevant MeSH terms:
Emergencies
Sprains and Strains
Ankle Injuries
Disease Attributes
Pathologic Processes
Wounds and Injuries
Leg Injuries