Study of N-Acetylcysteine Injection to Protect Cartilage After Pilon Fracture Preventing Cartilage Cell Death and Post-Traumatic Osteoarthritis in Ankle Injuries

What this Trial Is About

Researchers are studying the effects of an intra-articular injection of N-acetylcysteine NAC on cartilage cell survival after high energy pilon fractures of the distal tibia, which are serious ankle injuries often leading to post-traumatic osteoarthritis PTOA. These fractures commonly result from motor vehicle collisions, and despite current treatments, over half of patients develop PTOA within two years. The study aims to see if NAC can reduce cartilage cell death and potentially lower the risk of PTOA. Participants will receive either a 4 mL injection of 20% NAC solution or a 4 mL injection of 20% saline placebo into the ankle joint at the time of external fixation surgery. This injection occurs during the initial staged procedure used to stabilize the fracture before definitive internal fixation. The study uses a randomized, double-blind design to compare the effects of NAC versus saline. During the study, researchers will assess cartilage cell viability at the time of the definitive surgery, which typically happens after the soft tissue has healed sufficiently following external fixation. Participants will be monitored for changes in cartilage cell survival, and safety will be tracked throughout. The trial is sponsored by the University of Missouri-Columbia and plans to evaluate outcomes until 2026.

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