Treatment for Pilon Fractures with N-Acetylcysteine Injection
Prevention of Cartilage Cell Death Following a Pilon Fracture With Intra-articular Injection of N-Acetylcysteine (Pilon NAC)
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 |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT03652753 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with closed high energy pilon fractures requiring a staged surgical procedure.
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.
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 performed: While the use of NAC in this context is novel, other studies have explored its benefits in different orthopedic applications, suggesting potential for success.
Eligibility criteria
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 this trial is running
Columbia, Missouri
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.