NCT01518335

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Albert Einstein Healthcare Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sprain of Ankle

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-01-01
• Completion: 2012-02-01
• First posted: 2012-01-26
• Last updated: 2017-05-10

Locations

1 site across 1 country: United States