Can a special brace stop ankle arthritis after a break?
NCT ID NCT04562896
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether custom carbon fiber braces can reduce harmful forces on the ankle joint after a fracture, which may lower the risk of developing arthritis. Twenty-two adults with healed ankle fractures walked with and without different brace designs while researchers measured joint stress and foot pressure. The goal was to find the best brace shape to protect ankle cartilage and guide future treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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.
- Participants
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22 people
The number who actually took part.
- Started
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Jan 2020
- Finished
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Oct 2023
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
TIBIAL PILON FRACTURE PARTICIPANTS: Inclusion Criteria: * Ages: 18-65 * Sustained unilateral fracture of the tibial pilon within the preceding 5 years * 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 13 * Ability to read and write in English and provide written informed consent * Individuals with elevated contact stress according to model generated using PedCAT 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. HEALTHY ABLE-BODIED PARTICIPANTS: Patient Inclusion Criteria * Between the ages of 18 and 65 * Shoe size between women's 8 and 13.5 or men's 6.5 and 13 * Healthy individuals without a current complaint of lower extremity pain, spine pain, or medical or neuromusculoskeletal disorders that have limited participation in work or exercise in the last 6 months * Full active range of motion of the bilateral lower extremities and spine * Ability to hop without pain * Ability to perform a full squat without pain * Ability to read and write in English and provide written informed consent Patient Exclusion Criteria * Diagnosed moderate or severe brain injury * Prior lower extremity injury resulting in surgery or limiting function for greater than 6 weeks * Diagnosis of a physical or psychological condition that would preclude testing (e.g. cardiac condition, clotting disorder, pulmonary condition) * Visual or hearing impairment that would interfere with instructions given during testing * Require an assistive device * Wounds to the foot or calf that would prevent CDO use * 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Iowa
Iowa City, Iowa, 52242, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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