Custom Dynamic Orthoses to Reduce Articular Contact Stress

NCT05209347 | Withdrawn FDA Device

• 2 other identifiers: 202112331CDMRP-PR172087
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Post-traumatic Osteoarthritis; Osteoarthritis Ankle; Ankle Fractures

Keywords

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

Outcome Measures

Primary Outcomes (11)

• Joint Contact Stress Exposure (Model estimated)

  Joint contact stress exposure (MPA-s/gait cycle) will be estimated using a participant specific musculoskeletal model.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline

Secondary Outcomes (8)

• Four Square Step Test (4SST)

  Baseline

• Sit to Stand 5 Times (STS5)

  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 (3)

NoCDO

NO INTERVENTION

Participants will be evaluated without a CDO

CDO-A

EXPERIMENTAL

The first study CDO will be designated CDO-A

Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

CDO-B

EXPERIMENTAL

The second study CDO will be designated CDO-B

Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

Interventions

Carbon Fiber Custom Dynamic Orthosis (CDO) DEVICE

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.

Also known as: Ankle Foot Orthosis (AFO)

CDO-A; CDO-B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

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.

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52241, 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

Study Officials

• Jason M Wilken, PT, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the different CDO designs and will only be introduced to each device as CDO-A or CDO-B.
• 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 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.

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 26, 2022
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 15, 2026

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)