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

NCT01518335 | Completed DMC

• 1 other identifier: HN4157
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Sprain of Ankle

Keywords

platelet rich plasma; ankle; sprain; injection; Platelet Rich Plasma therapy; focal, invasive therapy for sprains

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in pain from baseline

  Day 0; Day 2-3, Day 8-10, Day 30

Study Arms (2)

Platelet Rich Plasma

EXPERIMENTAL

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

Procedure: Platelet rich plasma injection

Placebo/Standard of Care

PLACEBO COMPARATOR

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

Interventions

Platelet rich plasma injection 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.

Platelet Rich Plasma

Placebo Comparator: Placebo/Standard of Care 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.

Placebo/Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• severe ankle sprain
• X-ray completed

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Ankle Injuries; Sprains and Strains

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Adam Rowden, DO

  Eisntein Healthcare Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: January 26, 2012
• Study Start: June 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2012
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)