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Study identifier: NCT03652753 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Pilon Fracture With Intra-articular Injection of N-Acetylcysteine (Pilon NAC)

Condition: Pilon Fracture  ·  Sponsor: University of Missouri-Columbia

PhasePhase 4
Planned participants30
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 lik…

This description comes directly from the study's public registry record.

Talk to the study team

Vicki Jones, MEd, CCRP  ·  (573) 882-7583  ·  jonesvicki@health.missouri.edu

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Locations (1)

University of Missouri Health SystemColumbia, Missouri, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT03652753