CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
Arthrocentesis/PRP +1 morebiological
Likely dose
Arthrocentesis/PRP 5 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02481869
NCT02481869N/ACompleted

Does Early Platelet Rich Plasma Injection Decrease the Risk of Post-traumatic Arthritis in Pilon Fractures Undergoing Two-staged Open Reduction With Internal Fixation?

University of Missouri-Columbia·interventional·Posted Jun 25, 2015·Updated Feb 5, 2021

In Brief

A clinical study evaluating Arthrocentesis/PRP and Arthrocentesis/Saline for Fracture. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFracture
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 25, 2015
Enrollment StartJun 1, 2015
Primary CompletionNov 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 11.0 years ago

Interventions

Arthrocentesis/PRPbiological

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

Arthrocentesis/Salinedrug

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