Treatment for Pilon Fractures with N-Acetylcysteine Injection
Official title: Prevention of Cartilage Cell Death Following a Pilon Fracture With Intra-articular Injection of N-Acetylcysteine (Pilon NAC)
Run by University of Missouri-Columbia · NCT03652753 · Data updated 2026-11-12
This study is testing if an injection of N-acetylcysteine can help people with high energy pilon fractures avoid developing arthritis after their injury.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Status | Recruiting |
| Started | January 1, 2019 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | April 28, 2026 |
| Trial ID | NCT03652753 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with closed high energy pilon fractures requiring a staged surgical procedure.
✕Probably not a fit
Patients with open fractures, intra-articular injuries not requiring a staged procedure, or those with allergies to NAC may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of N-acetylcysteine (NAC) as an intra-articular injection for patients with high energy pilon fractures. The study aims to assess whether NAC can reduce the incidence of post-traumatic osteoarthritis (PTOA), a common complication following these injuries. Participants will receive either NAC or saline as a control during a staged surgical procedure. The trial is designed to evaluate the effectiveness of NAC in improving long-term outcomes for patients suffering from this type of fracture.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of developing post-traumatic osteoarthritis in patients with pilon fractures.
How similar studies have gone: While the use of NAC in this context is novel, other studies have explored its benefits in different orthopedic applications, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Closed high energy pilon fracture requiring a staged procedure Exclusion Criteria: * Younger than 18 * Open fracture * Intra-articular injury not requiring a staged procedure * Allergy to NAC * Wounds preventing safe intra-articular injection * Unwilling to participate in the study * Pregnancy
Where it's running
-
University of Missouri Health System
Columbia, Missouri, United States Recruiting
Study contacts
- Study coordinator: Vicki Jones, MEd, CCRP
- Email: jonesvicki@health.missouri.edu
- Phone: (573) 882-7583
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Simplified rehabilitation for ankle and pilon fractures
This study tests if a simple wooden block stretching routine can help people recover from ankle and pilon fractures just as well as regular physical therapy.
-
Comparing two surgical methods for treating ankle fractures in elderly patients
This study is testing which surgical method works better for treating ankle fractures in frail elderly patients: a fusion surgery or a method that uses plates and screws.
-
Talar Osteochondral Lesions in Pilon Fractures: Nano-Arthroscopy During External Fixation
This study tests whether tiny ankle arthroscopy during external fixation can find talar cartilage lesions in adults with pilon fractures and help plan future treatment.
-
Fibergraft Aeridyan bone graft for open pilon fractures
This observational study will see if using Fibergraft Aeridyan bone graft matrix helps adults with open pilon fractures heal with fewer infections and nonunions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.