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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: Recruiting Phase 4 study of Pilon Fracture, sponsored by University of Missouri-Columbia.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
During the definitive surgery we will take a cartilage biopsy and analyze for cell viability.
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 |
What NCT03652753 shows while recruiting
NCT03652753 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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
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Where NCT03652753's enrollment target sits among peer trials
30 1552nd of 2000 higher than 368 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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