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Antioxidant

N-Acetylcysteine Injection for Pilon Fracture

Phase 4
Recruiting
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Closed high energy pilon fracture requiring a staged procedure
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of definitive surgery
Awards & highlights

Study Summary

This trial will examine the effects of an amino acid, N-acetylcysteine (NAC), on cartilage cells after an intra-articular fracture of the ankle joint. The goal is to reduce the incidence of post-traumatic osteoarthritis (PTOA) in the ankle joint after fracture.

Who is the study for?
This trial is for adults with a closed high-energy pilon fracture needing staged surgery. It's not for those under 18, with open fractures, NAC allergies, wounds that prevent safe injection, unwillingness to participate, pregnancy or if the injury doesn't require staged procedures.Check my eligibility
What is being tested?
The study tests whether injecting N-acetylcysteine (NAC) into the ankle joint after a pilon fracture can keep more cartilage cells alive compared to a placebo saline injection. The aim is to see if this can reduce post-traumatic osteoarthritis.See study design
What are the potential side effects?
While NAC has been deemed safe for intra-articular and systemic injections in humans, potential side effects may include local reactions at the injection site or allergic responses in those sensitive to its components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a severe fracture in your leg that needs to be treated with multiple surgeries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of definitive surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of definitive surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cartilage Cell Viability

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: N-acetylcysteine (NAC)Experimental Treatment1 Intervention
Injection of N-acetylcysteine at the time of external fixation
Group II: SalinePlacebo Group1 Intervention
Injection of saline at the time of external fixation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetylcysteine
FDA approved

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
360 Previous Clinical Trials
627,934 Total Patients Enrolled

Media Library

N-acetylcysteine (Antioxidant) Clinical Trial Eligibility Overview. Trial Name: NCT03652753 — Phase 4
Pilon Fracture Research Study Groups: N-acetylcysteine (NAC), Saline
Pilon Fracture Clinical Trial 2023: N-acetylcysteine Highlights & Side Effects. Trial Name: NCT03652753 — Phase 4
N-acetylcysteine (Antioxidant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03652753 — Phase 4
Pilon Fracture Patient Testimony for trial: Trial Name: NCT03652753 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients still being enrolled in this research program?

"That is correct, the clinical trial mentioned is still ongoing and looking for 30 individuals from 1 locations. The information was last updated on 11/2/2022 after being posted on 1/1/2019."

Answered by AI

What illnesses does N-acetylcysteine help to treat?

"N-acetylcysteine is often used to heal corneal ulcerations. Additionally, this medication can be effective in treating acute rhinitis, acetaminophen poisoning, and other corneal diseases."

Answered by AI

How many study subjects are you testing your hypothesis on?

"That is correct. The information available on clinicaltrials.gov suggests that this particular trial is recruiting patients at the moment. This specific trial was first posted on 1/1/2019 and underwent its most recent update on 11/2/2022. 30 individuals are needed to participate at a single location."

Answered by AI

Does N-acetylcysteine have the medical community's seal of approval?

"N-acetylcysteine is a phase 4 medication, so it has been approved and Power rates it as having a safety of 3."

Answered by AI

What is the precedent for N-acetylcysteine research?

"As of right now, there are 40 ongoing scientific investigations related to N-acetylcysteine. Out of those 7 are large clinical trials in their third and final phase. Most of the research is based out of New york City, but there are a total 46 locations running these sorts of tests."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
What site did they apply to?
University of Missouri Health System
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I need compensation and I've been living with this pain since 2005.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. University of Missouri Health System: < 48 hours
Typically responds via
Phone Call
~4 spots leftby Jan 2025