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Ankle brace study pulled before it even started

NCT ID NCT05209347

Knowledge-focused Sponsor: University of Iowa 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 Results may not be published yet.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
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to see if custom carbon fiber braces could reduce forces on the ankle joint after a fracture, potentially lowering the risk of arthritis. It planned to enroll adults with healed ankle fractures and test different brace designs. However, the study was withdrawn before any participants were enrolled, so no data was collected.

What this could mean

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

Active substance
Carbon Fiber Custom Dynamic Orthosis (CDO) - a brace
What this could lead to
If successful, this could help design braces that lower the chance of developing ankle arthritis after a fracture.
What could go wrong
The study was withdrawn before any participants enrolled, so no results are available. It is unclear if the braces actually reduce arthritis risk.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Expected to start

Dec 2024

An estimate. Start dates often move.

Expected to finish

Dec 2025

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 to 65 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: * Between the ages of 18 and 65 * Sustained unilateral fracture of the tibial pilon * The fracture has completely healed * Ability to walk 50 feet without use of an assistive device (cane, crutch, etc.) * Ability to walk at a slow to moderate pace * Shoe size between women's 8 and 13.5 or men's 6.5 and 12 * Ability to read and write in English and provide written informed consent * Individuals with elevated contact stress according to model generated using standing CT images (will be answered after completing visit one) Exclusion Criteria: * Pain \> 6/10 while walking * Increase in pain during testing of 3/10 or greater * Neurologic, musculoskeletal (including bilateral fractures) or other condition limiting function of the contralateral extremity * Medical or psychological condition that would preclude functional testing (ex. moderate or severe brain injury, stroke, heart disease) * Wounds to the calf that would prevent CDO fitting * Fractures secondary to neuropathy or severe osteopenia * Classification as non-ambulatory * Previous fractures near the tibial pilon on the involved limb * Surgery on involved limb anticipated in the next 6 months * Requirement of a knee stabilizing device (i.e. KAFO, KO…) to perform daily activities * Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing * BMI greater than 40 * Pregnancy- Per participant self-report. Due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, participants will be withdrawn from the study.

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Conditions

The condition(s) this trial relates to.

Ankle Fractures arthritic joint disease osteoarthritis tibia fracture

As listed by the trial registrant

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

Ankle fractures Osteoarthritis, ankle Post-traumatic osteoarthritis

Contacts and locations

Locations

  • University of Iowa

    Iowa City, Iowa, 52241, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.