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

Albert Einstein Healthcare Network

Status: Completed

Conditions: Sprain of Ankle

Treatments: Procedure: Placebo Comparator: Placebo/Standard of Care; Procedure: Platelet rich plasma injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01518335

HN4157

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups, including a placebo group

Platelet Rich Plasma

Experimental group

Description:

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

Treatment:

Procedure: Platelet rich plasma injection

Placebo/Standard of Care

Placebo Comparator group

Description:

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

Treatment:

Procedure: Placebo Comparator: Placebo/Standard of Care