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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sprain of Ankle

Intervention / Treatment
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* Procedure: Platelet rich plasma injection
* Procedure: Placebo Comparator: Placebo/Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet Rich Plasma<br>Patients receive Platelet rich plasma injection + standard of care therapy(bandaging or boot and crutches) + non-NSAID pain medicine | Procedure: Platelet rich plasma injection<br>* 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.<br>|
| Placebo Comparator: Placebo/Standard of Care<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet rich plasma, ankle, sprain, injection, Platelet Rich Plasma therapy, focal, invasive therapy for sprains