Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress
Completed · Not applicable
Conditions studied: Ankle Fractures, Post-traumatic Osteoarthritis, Osteoarthritis Ankle
In brief
The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. Research suggests that ankle arthritis develops after ankle fracture, in part, due to elevated forces on the cartilage. It is expected that carbon fiber braces can be designed to reduce forces in the ankle joint and thereby reduce the risk of developing arthritis following traumatic injury. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The proposed study will provide evidence that can be used by clinicians and researchers to design braces that most effectively reduce forces on ankle cartilage.
Key facts
- Study ID
- NCT04562896
- Run by
- University of Iowa
- People needed
- 22
- Starts
- 2020-01-08
- Expected to finish
- 2023-10-05
- Last updated by the study team
- 2026-01-30
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- University of Iowa — Iowa City, Iowa, United States
Full record on ClinicalTrials.gov
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