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Completed

NCT Number: NCT01518335

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.

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Key information

Conditions

Sprain of Ankle Ankle Injuries Leg Injuries Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet Rich Plasma injection

Procedure

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

Procedure

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.

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Albert Einstein Healthcare Network

Other

Registry information

Official study title

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

Acronym: PRP

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 26, 2012
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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