Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress

NCT04562896 | Completed Results FDA Device

• 2 other identifiers: 202002769CDMRP-PR172087
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ankle Fractures; Osteoarthritis Ankle; Post-traumatic Osteoarthritis

Keywords

Carbon Fiber; Gait Analysis; Ankle Foot Orthosis; Arthritis; Biomechanics; Ankle; Adult

Outcome Measures

Primary Outcomes (16)

• Joint Contact Stress Time Exposure (Model Estimated)

  Joint contact stress time exposure (MPA-s/gait cycle) was estimated using a participant specific musculoskeletal model. Peak joint contact stress time exposure (MPA-s/gait cycle) acting on the tibia during the gait cycle were reported. Lower peak contact stress time exposure is considered a better outcome.

  Baseline

• Peak Plantar Force (Total Foot)

  Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (100% of sensor) and normalized to participant body weight as they walk.

  Baseline

• Peak Plantar Force (Hindfoot)

  Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (proximal 30% of sensor) as participants walk without a CDO and with each CDO.

  Baseline

• Peak Plantar Force (Midfoot)

  Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (middle 30% of sensor) as participants walk without a CDO and with each CDO.

  Baseline

• Peak Plantar Force (Forefoot)

  Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (distal 40% of sensor) as participants walk without a CDO and with each CDO.

  Baseline

• Plantar Force Impulse (Total Foot)

  Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (100% of sensor) will be calculated using the integral of the force over the stance phase and normalized to participant body weight as they walk.

  Baseline

• Plantar Force Impulse (Hindfoot)

  Plantar force impulse normalized to body weight (Ns/kg) 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.

  Baseline

• Plantar Force Impulse (Midfoot)

  Plantar force impulse normalized to body weight (Ns/kg) 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.

  Baseline

• Plantar Force Impulse (Forefoot)

  Plantar force impulse normalized to body weight (Ns/kg) 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.

  Baseline

• Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS)

  Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. Lower values are better as they indicate less pain.

  Baseline

• Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS)

  Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. Lower values are better as they indicate less pain

  Baseline

• Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC)

  The participant will rank order their preference for their standard of care device (if applicable), No Device, CDO-A, CDO-B, CDO-C on a questionnaire.

  Baseline

• Participant Device Preference (First Preferred Condition)

  Participants were asked to rank order their preference for NoCDO, CDO-A, CDO-B, CDO-C on a questionnaire.

  Baseline

• Participant Device Preference (Second Preferred Condition)

  Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).

  Baseline

• Participant Device Preference (Third Preferred Condition)

  Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).

  Baseline

• Participant Device Preference (Fourth Preferred Condition)

  Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).

  Baseline

Secondary Outcomes (10)

• Peak Soleus Muscle Force (Model Estimated)

  Baseline

• Peak Gastrocnemius Muscle Force (Model Estimated)

  Baseline

• Ankle Range of Motion

  Baseline

• Peak Ankle Moment

  Baseline

• Peak Ankle Power

  Baseline

Other Outcomes (8)

• Semi-Structured Interview

  Baseline

• Center of Pressure Velocity Timing

  Baseline

• Center of Pressure Velocity Magnitude

  Baseline

Study Arms (4)

No Device

NO INTERVENTION

Participants will be evaluated without a CDO.

CDO-A

EXPERIMENTAL

The first design variant will be designated CDO-A

Device: Custom Carbon Fiber Dynamic Orthosis (CDO)

CDO-B

EXPERIMENTAL

The second design variant will be designated CDO-B

Device: Custom Carbon Fiber Dynamic Orthosis (CDO)

CDO-C

EXPERIMENTAL

The third design variant will be designated CDO-C

Device: Custom Carbon Fiber Dynamic Orthosis (CDO)

Interventions

Custom Carbon Fiber Dynamic Orthosis (CDO) DEVICE

The custom carbon fiber dynamic orthoses will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.

Also known as: Ankle Foot Orthosis

CDO-A; CDO-B; CDO-C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• Between the ages of 18 and 65

Sponsors & Collaborators

• University of Iowa: lead
• Bio-Mechanical Composites: collaborator
• Fabtech Systems: collaborator
• University of Delaware: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Ankle Fractures; Arthritis

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Jason M. Wilken, PT, PhD
• Organization: The University of Iowa

jason-wilken@uiowa.edu

319-335-6857

Study Officials

• Jason M Wilken, PT, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the different design variations of each device, and will only be introduced to each device as CDO-A, CDO-B or CDO-C.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Collaborative Research and Development, Associate Professor

Model Details: All participants will be cast and fit with three carbon fiber custom dynamic orthoses (CDOs). Each CDO will differ from the others in design and will be labeled as CDO-A, CDO-B and CDO-C. Participants will be randomly assigned to one of six CDO testing sequences (ABC, ACB, BCA, BAC, CAB, CBA) to prevent testing order from influencing study results. Multiple rounds of evaluation (\~5 rounds) with small groups of participants in each round (n=\~6) will be used.

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 24, 2020
• Study Start: January 8, 2020
• Primary Completion: October 5, 2023
• Study Completion: October 5, 2023
• Last Updated: January 30, 2026
• Results First Posted: January 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)