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

Sprain of Ankle Clinical Trial

— PRP  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518335
• Other study ID #: HN4157
• Status: Completed
• Phase: N/A
• First received: December 8, 2011
• Last updated: May 8, 2017
• Start date: June 2009
• Est. completion date: February 2012

Study information

• Verified date: May 2017
• Source: Albert Einstein Healthcare Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Emergencies
• Sprain of Ankle
• Sprains and Strains

Intervention

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
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.

Locations

Country	Name	City	State
United States	Einstein Healthcare Network	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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