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Could a single injection after ankle surgery ward off arthritis?

NCT ID NCT04589611

Disease control Sponsor: J L Marsh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study tests whether a drug called amobarbital, injected into the ankle joint during fracture repair surgery, can prevent post-traumatic osteoarthritis. The trial involves 5 adults aged 18–60 with severe ankle fractures. The main goal is to check safety, but researchers will also look for signs that the treatment protects cartilage and reduces joint inflammation.

What this could mean

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

Active substance
amobarbital (with hyaluronic acid)
What this could lead to
If successful, this approach could reduce the risk of arthritis after severe ankle fractures, potentially preserving joint function and avoiding long-term pain.
What could go wrong
This is a very early, small trial with only 5 participants, primarily testing safety. The treatment may not prove effective, and amobarbital could cause side effects or fail to prevent arthritis.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

5 people

The number who actually took part.

Started

Jul 2022

Finished

May 2025

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 to 60 years

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: * Age 18-60 years * Acute closed or type 1 open ankle fractures (classified as OTA/AO 43 B 1-3 and 43 C 1- 3 or classified as 42 B and C fractures with 25% talar displacement and one of the following; syndesmosis injury or medial malleolar fracture at or above the shoulder) (Marsh et al., 2007)) without operative ipsilateral extremity trauma * Posterior malleolar and supination adduction rotational fractures that have an articular fracture line across the articular surface of the distal tibia. Posterior malleolar fractures should affect 25% of the articular surface or greater. * Fractures must have initial treatment within 72 hours of injury including initial injection of amobarbital or placebo. Exclusion Criteria: * Diabetes * Pregnant or nursing mothers and individuals with child-bearing potential that are not using birth control methods with \>99% efficacy. * Allergy to poultry products or cinnamon * Previous injuries to the ankle * High grade open wounds * Pre-existing immunologic or hematologic diseases * Pre-existing ankle arthritis * Ipsilateral fractures * Associated injuries that preclude standard rehabilitation * Pre-existing dysfunction of the kidneys, liver, blood, immune system, endocrine system (excluding diabetes) * Serum creatinine \>/= 1.4 mg/dl; BUN \> 30 mg/dl; ALT \>/= 60 IU/L in males and \>/= 50 IU/L in females; AST \>/= 45 IU/L in males and \> 40 IU/L in females; bilirubin \> 1.3 mg/dL; platelets \</= 50,000/ul; glucose \> 200 mg/dL

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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.

Osteoarthritis Post-traumatic osteoarthritis

Contacts and locations

Locations

  • University of Iowa

    Iowa City, Iowa, 52240, United States

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