Status:
WITHDRAWN
Custom Dynamic Orthoses to Reduce Articular Contact Stress
Lead Sponsor:
University of Iowa
Conditions:
Ankle Fractures
Post-traumatic Osteoarthritis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 forc...
Detailed Description
The primary purpose of this line of research is to investigate the effects of carbon fiber custom dynamic orthosis (CDO) use on forces and contact stress at the ankle, with the goal of reducing the de...
Eligibility Criteria
Inclusion
- 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
- 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of pregnant individuals and resulting inability to account for its effect on resulting outcomes, participants will be withdrawn from the study.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05209347
Start Date
December 1 2024
End Date
December 1 2025
Last Update
December 14 2023
Active Locations (1)
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1
University of Iowa
Iowa City, Iowa, United States, 52241