N/A N=22 Randomized Single-blind Other

Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress

Ankle Fractures · Post-traumatic Osteoarthritis · Osteoarthritis Ankle

Bottom Line

View on ClinicalTrials.gov: NCT04562896 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Joint Contact Stress Time Exposure (Model Estimated) — 4.44; 3.97; 4.08; 4.25 MPa-s/gait cycle

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Custom Carbon Fiber Dynamic Orthosis (CDO) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Iowa
Primary completion: Oct 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Joint Contact Stress Time Exposure (Model Estimated)	4.44; 3.97; 4.08; 4.25	—
PRIMARY Peak Plantar Force (Total Foot)	11.3; 10.5; 10.7; 10.4; 11.0; 10.6	—
PRIMARY Peak Plantar Force (Hindfoot)	8.7; 7.2; 7.7; 7.5; 9.2; 8.2	—
PRIMARY Peak Plantar Force (Midfoot)	3.0; 2.8; 3.1; 2.9; 2.5; 1.6	—
PRIMARY Peak Plantar Force (Forefoot)	9.7; 7.7; 7.7; 7.7; 9.0; 7.1	—
PRIMARY Plantar Force Impulse (Total Foot)	5.8; 5.7; 6.0; 5.7; 5.4; 5.8	—
PRIMARY Plantar Force Impulse (Hindfoot)	2.0; 2.2; 2.5; 2.2; 2.1; 2.6	—
PRIMARY Plantar Force Impulse (Midfoot)	1.1; 1.3; 1.3; 1.2; 0.8; 0.6	—
PRIMARY Plantar Force Impulse (Forefoot)	2.7; 2.3; 2.2; 2.3; 2.5; 2.6	—
PRIMARY Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS)	0.6; 0.4; 0.4; 0.6; 0.0; 0.0	—
PRIMARY Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS)	0.9; 0.4; 0.6; 0.4; 0.0; 0.0	—
PRIMARY Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC)	1; 1; 1; 2; 1; 1	—
PRIMARY Participant Device Preference (First Preferred Condition)	4; 0; 0; 3; 5; 1	—
PRIMARY Participant Device Preference (Second Preferred Condition)	1; 2; 1; 3; 1; 1	—
PRIMARY Participant Device Preference (Third Preferred Condition)	1; 2; 3; 1; 0; 0	—
PRIMARY Participant Device Preference (Fourth Preferred Condition)	1; 3; 3; 0; 0; 4	—
SECONDARY Peak Soleus Muscle Force (Model Estimated)	2014.4; 1344.8; 1529.6; 1534.5	—
SECONDARY Peak Gastrocnemius Muscle Force (Model Estimated)	1670.3; 1425.4; 1568.0; 1593.4	—
SECONDARY Ankle Range of Motion	17.0; 13.3; 12.9; 13.6; 16.3; 12.3	—
SECONDARY Peak Ankle Moment	1.5; 1.5; 1.5; 1.5; 1.4; 1.5	—
SECONDARY Peak Ankle Power	3.0; 1.2; 1.4; 1.6; 2.6; 1.4	—
SECONDARY Four Square Step Test (4SST)	6.6; 6.6; 6.5; 6.3; 7.1; 7.2	—
SECONDARY Sit to Stand 5 Times (STS5)	7.9; 8.8; 8.6; 8.4; 7.3; 9.7	—
SECONDARY The Orthotics Prosthetics Users' Survey (OPUS)	29.0; 30.3; 31.7; 23.3; 23.8; 26.0	—
SECONDARY Modified Socket Comfort Score (Comfort)	6.3; 6.4; 7.6; 7.0; 7.0; 7.7	—
SECONDARY Modified Socket Comfort Score (Smoothness)	6.1; 5.7; 7.7; 6.5; 6.8; 7.7	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04562896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.