Ankle FracturesPRMRP FPA CTNCT05209347
Custom Dynamic Orthoses to Reduce Articular Contact Stress
A study testing Carbon Fiber Custom Dynamic Orthosis (CDO) in people with Ankle Fractures and Post-traumatic Osteoarthritis, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Fractures, Post-traumatic Osteoarthritis, Osteoarthritis Ankle
- What is being tested?
- Carbon Fiber Custom Dynamic Orthosis (CDO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 development of post traumatic osteoarthritis (PTOA). Research suggests that PTO develops, in part, due to increased ankle contact stress following fracture. It is expected that reducing articular contact stress has the potential to delay or prevent PTOA development. CDOs have been shown to significantly improve function after extremity injury, and show promise for offloading the injured ankle joint after severe lower extremity injuries. Therefore, the proposed effort is designed to evaluate CDOs effects on forces and articular contact stress at the ankle.
Adult participants who have sustained a traumatic ankle fracture of the tibial pilon will be evaluated while wearing two CDOs, with a primary dependent measure of ankle joint contact stress. Following consent and enrollment weight bearing computerized tomography (CT) images will be collected and used to determine the geometry of the joint, and the articular contact stress using discrete element analysis.
Participants will be cast and fit for two CDOs. Participants will be blinded to the design variation of each device and will only know them as CDO-A or CDO-B. Testing will be completed under 3 conditions: No-CDO, CDO-A, CDO-B, with each bracing condition (A/B) representing a different CDO. Physical performance measures will incorporate tests of agility, speed, and lower limb power to ensure that the CDOs do not negatively affect physical function. Questionnaires will be used to evaluate participants' current and desired activity level, pain with and without using a CDO, satisfaction with the study CDOs, perception of comfort and smoothness between CDOs, and preference between CDOs. Semi-structured interviews will be completed to fully capture the participant's perspective with each study CDO. Lower limb forces and motion will be assessed using a computerized motion capture system and force plates embedded in the floor. Forces between the foot and CDO footplate will be measured using force sensing insoles, and muscle activity data will be collected using wireless surface electromyography sensors. Each CDO will be mechanically tested, and participant demographic and anthropometric data will be recorded.
- Being tested
- Carbon Fiber Custom Dynamic Orthosis (CDO)
- Keywords
- Carbon Fiber, Gait Analysis, Ankle Foot Orthosis, Arthritis, Biomechanics, Ankle, Adult
- Medical subject headings
- Ankle Fractures, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon Fiber Custom Dynamic Orthosis (CDO)Device
Also called Ankle Foot Orthosis (AFO)
The carbon fiber custom dynamic orthosis will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
| Study group | Role | What they receive |
|---|---|---|
| NoCDO | No intervention | Participants will be evaluated without a CDO |
| CDO-A | Experimental | The first study CDO will be designated CDO-A Receives: Device: Carbon Fiber Custom Dynamic Orthosis (CDO) |
| CDO-B | Experimental | The second study CDO will be designated CDO-B Receives: Device: Carbon Fiber Custom Dynamic Orthosis (CDO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Contact Stress Exposure (Model estimated)
Joint contact stress exposure (MPA-s/gait cycle) will be estimated using a participant specific musculoskeletal model.
Measured: Baseline
Peak Plantar Force (total foot)
Plantar forces (N) will be measured across the forefoot (100% of sensor) as participants walk without a CDO and with each CDO.
Measured: Baseline
Plantar Force Impulse (total foot)
Plantar force impulse (Ns) across the forefoot (100% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.
Measured: Baseline
Peak Plantar Force (forefoot)
Plantar forces (N) will be measured across the forefoot (distal 40% of sensor) as participants walk without a CDO and with each CDO.
Measured: Baseline
Plantar Force Impulse (forefoot)
Plantar force impulse (Ns) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.
Measured: Baseline
Peak Plantar Force (midfoot)
Plantar forces (N) will be measured across the forefoot (middle 30% of sensor) as participants walk without a CDO and with each CDO.
Measured: Baseline
Plantar Force Impulse (midfoot)
Plantar force impulse (Ns) across the forefoot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.
Measured: Baseline
Peak Plantar Force (hindfoot)
Plantar forces (N) will be measured across the forefoot (proximal 30% of sensor) as participants walk without a CDO and with each CDO.
Measured: Baseline
Plantar Force Impulse (hindfoot)
Plantar force impulse (Ns) across the forefoot (proximal 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.
Measured: Baseline
Numerical Pain Rating Scale
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
Measured: Baseline
Participant Device Preference
The participant will rank order their preference for their standard of care device (if applicable), NoCDO, CDO-A, CDO-B on a questionnaire.
Measured: Baseline
Secondary outcomes (8)
Four Square Step Test (4SST)
The 4SST (s) is a standardized timed test of balance and agility.
Measured: Baseline
Sit to Stand 5 Times (STS5)
STS5 (s) is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to stand up and sit down 5 times as fast as possible.
Measured: Baseline
Ankle Range of Motion
Ankle range of motion (degrees) during gait.
Measured: Baseline
Peak Ankle Moment
Peak ankle moment (Nm/kg) during gait.
Measured: Baseline
Peak Ankle Power
Peak ankle power (W/kg) during gait.
Measured: Baseline
The Orthotics Prosthetics Users' Survey (OPUS)
Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score (11-55). Lower scores indicate a better outcome.
Measured: Baseline
Modified Socket Comfort Score (Comfort)
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.
Measured: Baseline
Modified Socket Comfort Score (Smoothness)
Smoothness scores range from 0 = least smooth to 10 = most smooth.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Study related activities were delayed and effort was instead focused on recruitment and testing for the iterative design study (NCT04562896).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will be cast and fit with two CDOs. Each CDO will be labeled as CDO-A or CDO-B. Participants will be randomly assigned to one of two CDO testing sequences (AB, BA) to prevent testing order from influencing study results.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Wilken, University of Iowa
- Investigators
- Jason M Wilken, PT, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209347
- Sponsor's protocol ID
- 202112331
- Other IDs
- CDMRP-PR172087
- Acronym
- PRMRP FPA CT
- Status last verified
- Dec 2023
- First submitted
- 12 Jan 2022
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Custom Dynamic Orthoses to Reduce Articular Contact Stress
- ClinicalTrials.gov ID
- NCT05209347
- Acronym / sponsor ID
- PRMRP FPA CT / 202112331
- Keywords
- Carbon Fiber, Gait Analysis, Ankle Foot Orthosis, Arthritis, Biomechanics, Ankle, Adult
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study related activities were delayed and effort was instead focused on recruitment and testing for the iterative design study (NCT04562896).
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 development of post traumatic osteoarthritis (PTOA). Research suggests that PTO develops, in part, due to increased ankle contact stress following fracture. It is expected that reducing articular contact stress has the potential to delay or prevent PTOA development. CDOs have been shown to significantly improve function after extremity injury, and show promise for offloading the injured ankle joint after severe lower extremity injuries. Therefore, the proposed effort is designed to evaluate CDOs effects on forces and articular contact stress at the ankle.
Adult participants who have sustained a traumatic ankle fracture of the tibial pilon will be evaluated while wearing two CDOs, with a primary dependent measure of ankle joint contact stress. Following consent and enrollment weight bearing computerized tomography (CT) images will be collected and used to determine the geometry of the joint, and the articular contact stress using discrete element analysis.
Participants will be cast and fit for two CDOs. Participants will be blinded to the design variation of each device and will only know them as CDO-A or CDO-B. Testing will be completed under 3 conditions: No-CDO, CDO-A, CDO-B, with each bracing condition (A/B) representing a different CDO. Physical performance measures will incorporate tests of agility, speed, and lower limb power to ensure that the CDOs do not negatively affect physical function. Questionnaires will be used to evaluate participants' current and desired activity level, pain with and without using a CDO, satisfaction with the study CDOs, perception of comfort and smoothness between CDOs, and preference between CDOs. Semi-structured interviews will be completed to fully capture the participant's perspective with each study CDO. Lower limb forces and motion will be assessed using a computerized motion capture system and force plates embedded in the floor. Forces between the foot and CDO footplate will be measured using force sensing insoles, and muscle activity data will be collected using wireless surface electromyography sensors. Each CDO will be mechanically tested, and participant demographic and anthropometric data will be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- All participants will be cast and fit with two CDOs. Each CDO will be labeled as CDO-A or CDO-B. Participants will be randomly assigned to one of two CDO testing sequences (AB, BA) to prevent testing order from influencing study results.
| Arm | Type | Receives |
|---|---|---|
| NoCDO | No intervention | –Participants will be evaluated without a CDO |
| CDO-A | Experimental | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)The first study CDO will be designated CDO-A |
| CDO-B | Experimental | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)The second study CDO will be designated CDO-B |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon Fiber Custom Dynamic Orthosis (CDO)Also: Ankle Foot Orthosis (AFO)The carbon fiber custom dynamic orthosis will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. | Device | CDO-A, CDO-B |
Primary outcome
Joint Contact Stress Exposure (Model estimated)
Time frame: Baseline
Joint contact stress exposure (MPA-s/gait cycle) will be estimated using a participant specific musculoskeletal model.
Peak Plantar Force (total foot)
Time frame: Baseline
Plantar forces (N) will be measured across the forefoot (100% of sensor) as participants walk without a CDO and with each CDO.
Plantar Force Impulse (total foot)
Time frame: Baseline
Plantar force impulse (Ns) across the forefoot (100% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.
Peak Plantar Force (forefoot)
Time frame: Baseline
Plantar forces (N) will be measured across the forefoot (distal 40% of sensor) as participants walk without a CDO and with each CDO.
Plantar Force Impulse (forefoot)
Time frame: Baseline
Plantar force impulse (Ns) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.
Peak Plantar Force (midfoot)
Time frame: Baseline
Plantar forces (N) will be measured across the forefoot (middle 30% of sensor) as participants walk without a CDO and with each CDO.
Plantar Force Impulse (midfoot)
Time frame: Baseline
Plantar force impulse (Ns) across the forefoot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.
Peak Plantar Force (hindfoot)
Time frame: Baseline
Plantar forces (N) will be measured across the forefoot (proximal 30% of sensor) as participants walk without a CDO and with each CDO.
Plantar Force Impulse (hindfoot)
Time frame: Baseline
Plantar force impulse (Ns) across the forefoot (proximal 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.
Numerical Pain Rating Scale
Time frame: Baseline
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
Participant Device Preference
Time frame: Baseline
The participant will rank order their preference for their standard of care device (if applicable), NoCDO, CDO-A, CDO-B on a questionnaire.
8 secondary outcomes
Four Square Step Test (4SST)
Time frame: Baseline
Sit to Stand 5 Times (STS5)
Time frame: Baseline
Ankle Range of Motion
Time frame: Baseline
Peak Ankle Moment
Time frame: Baseline
Peak Ankle Power
Time frame: Baseline
The Orthotics Prosthetics Users' Survey (OPUS)
Time frame: Baseline
Modified Socket Comfort Score (Comfort)
Time frame: Baseline
Modified Socket Comfort Score (Smoothness)
Time frame: Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason M Wilken, PT, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon Fiber Custom Dynamic Orthosis (CDO) in people with Ankle Fractures and Post-traumatic Osteoarthritis, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint Contact Stress Exposure (Model estimated) (time frame: Baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.