A Double-Blind, Randomized, Placebo Controlled Study Evaluating the Use of Platelet Rich Plasma Therapy for Acute Ankle Sprains in the Emergency Department.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sprain of Ankle
- Sponsor
- Albert Einstein Healthcare Network
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Change from baseline of LEFS score, a previous validated 80-point scale used to quantify lower extremity function.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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.
Investigators
James Gardner, MD
MD
Albert Einstein Healthcare Network
Eligibility 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
Outcomes
Primary Outcomes
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
- Change in pain from baseline(Day 0; Day 2-3, Day 8-10, Day 30)