Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03652753 · ClinicalTrials.gov registry record · Phase 4
Pilon Fracture With Intra-articular Injection of N-Acetylcysteine (Pilon NAC)
A Phase 4 study of Pilon Fracture, sponsored by University of Missouri-Columbia.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03652753 is a Phase 4 study of Pilon Fracture that is actively recruiting participants, run by University of Missouri-Columbia. The registered enrollment target is 30 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03652753, a Phase 4 study of Pilon Fracture, is actively recruiting participants, sponsored by University of Missouri-Columbia.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
High energy intra-articular fractures of the distal tibia, or Pilon fracture, is a devastating injury with multiple short and long term complications. The incidence of these injuries is increasing as survival rates after motor vehicle collisions increase. The current standard of care for high energy pilon fractures is to place an external fixator at the time of injury and then provide definitive internal fixation when the soft tissue envelope allows, which is usually around 10-14 days. Arguably, the most debilitating long term complication after a high energy pilon fracture is the development of post-traumatic osteoarthritis (PTOA), which occurs in 50% or more of pilon fractures within the first 2 years of surgery. The development of osteoarthritis occurs even in the presence of adequate restoration of the tibial plafond. Part of this issue lies in the fact that ankle joint cartilage is the thinnest of any major articular joint and sustains a great deal of damage at the time of injury. This impaction and injury initiates a cascade of events that ultimately result in cartilage cell death, or chondrolysis. Chondrolysis occurs via necrosis or apoptosis. Apoptosis occurs via a caspase pathway, while necrosis of chondrocytes likely occurs secondary to overproduction of reactive oxidant species (ROS). Recent animal models have demonstrated several things: chondrocyte death is highest along fracture lines, and likely undergo necrosis as opposed to apoptosis. The reason that PTOA likely occurs in such a high percentage of pilon fractures is because of this chondrolysis, and if a method can be developed to decrease the rate of chrondrocyte necrosis, then the rate of PTOA could potentially improve and improve patient outcomes overall. A recent bovine model examined the injection of N-acetylcysteine (NAC) after an intra-articular knee fracture and its effect on the cartilage cell viability. Their study demonstrated that chondrocyte cell viability after an injection of NAC with
Conditions Studied
Interventions
- DRUG Saline
- DRUG N-acetylcysteine
Study Locations (1)
Missouri
- University of Missouri Health System - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-01-01 |
| Est. Completion | 2026-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03652753
The ClinicalTrials.gov registry entry for NCT03652753 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pilon Fracture appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.
NCT03652753 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT03652753 about?
NCT03652753 is a clinical study titled "Pilon Fracture With Intra-articular Injection of N-Acetylcysteine (Pilon NAC)". High energy intra-articular fractures of the distal tibia, or Pilon fracture, is a devastating injury with multiple short and long term complications. The incidence of these injuries is increasing as survival rates after motor vehicle collisions increase. The current standard of care for high energy...
What is the current status of trial NCT03652753?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2019-01-01. Estimated completion is 2026-01.
What conditions does trial NCT03652753 study?
This clinical trial studies the following conditions: Pilon Fracture.
What interventions are being tested in trial NCT03652753?
The interventions under investigation include: Saline (DRUG), N-acetylcysteine (DRUG).
Who is sponsoring clinical trial NCT03652753?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03652753 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pilon Fracture
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.