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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-02-29

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.

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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.

Conditions

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Sprain of Ankle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Platelet Rich Plasma

Patients receive Platelet rich plasma injection + standard of care therapy(bandaging or boot and crutches) + non-NSAID pain medicine

Group Type EXPERIMENTAL

Platelet rich plasma injection

Intervention Type 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/Standard of Care

Patient receives Placebo Comparator: Placebo/Standard of Care \[saline injection + standard of care (bandaging or boot and crutches)\] + non-NSAID pain medicine

Group Type PLACEBO_COMPARATOR

Placebo Comparator: Placebo/Standard of Care

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No