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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:
Information provided by (Responsible Party):
Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier:
NCT01518335
First received: December 8, 2011
Last updated: February 11, 2013
Last verified: January 2012
History of Changes
  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 Phase
Sprain of Ankle
 Procedure: Platelet rich plasma injection
Procedure: Placebo Comparator: Placebo/Standard of Care
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT01518335     History of Changes
Other Study ID Numbers: HN4157
Study First Received: December 8, 2011
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on June 18, 2013