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Could a simple injection after a broken ankle prevent arthritis?

NCT ID NCT03652753

Disease control Sponsor: University of Missouri-Columbia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether injecting N-acetylcysteine (NAC), an antioxidant, into the ankle right after a severe pilon fracture can keep cartilage cells alive and reduce the chance of developing post-traumatic arthritis. Thirty adults with closed high-energy pilon fractures will receive either NAC or a saline placebo during their initial surgery. The researchers will then check cartilage cell health during the follow-up surgery about two weeks later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
N-acetylcysteine
What this could lead to
If it works, this could point toward a simple injection to prevent arthritis after severe ankle fractures.
What could go wrong
This is a very small early-phase trial with only 30 people, and it is testing a lab-measured outcome (cell viability) rather than long-term arthritis prevention. The effect seen in animals may not translate to humans.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

tibia fracture osteoarthritis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pilon fracture

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Missouri Health System

    RECRUITING

    Columbia, Missouri, 65212, United States

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