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Platelet Rich Plasma Injection in Pilon Fractures

NCT02481869 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-02-05

Study results available
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Summary

Patients who sustain broken ankles have a very high risk of developing arthritis soon after injury (within 2 years). This arthritis can cause increased pain and a decrease level of function, especially if the injury occurs at an early age. During and shortly after ankle injury, there is an inflammatory chemical process that takes place in the ankle that can cause damage to the cartilage in the ankle joint. The investigators want to use what is called Platelet Rich Plasma (PRP), which is produced from a small amount of the patient's own blood, to inject into the injured ankle to see if they can decrease the inflammation that happens after the injury and to see if they can decrease arthritis.

Conditions

  • Fracture

Interventions

BIOLOGICAL

Arthrocentesis/PRP

PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-spanning external fixation

DRUG

Arthrocentesis/Saline

Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation

Sponsors & Collaborators

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Brett D Crist, MD · University of Missouri-Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2019-11-30
Completion
2019-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02481869 on ClinicalTrials.gov