Custom Dynamic Orthoses to Reduce Articular Contact Stress
Stopped: Study related activities were delayed and effort was instead focused on recruitment and testing for the iterative design study (NCT04562896).
United States0Started 2024-12
Plain-language summary
The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle. Research suggests that ankle arthritis develops following ankle fracture due, in part, to elevated forces on the cartilage. It is expected that carbon fiber braces can reduce forces in the ankle joint thereby reducing the risk of developing arthritis following injury. In this study, carbon fiber braces will be tested to determine how they influence the forces acting on the ankle cartilage. The proposed study will provide evidence that can be used by clinicians and researchers to design carbon fiber braces to effectively reduce forces on ankle cartilage.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.