Custom Dynamic Orthoses to Reduce Articular Contact Stress

NCT ID: NCT05209347

Last Updated: 2023-12-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Ankle Fractures; Post-traumatic Osteoarthritis; Osteoarthritis Ankle

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

NoCDO

Participants will be evaluated without a CDO

Group Type: NO_INTERVENTION

No interventions assigned to this group

CDO-A

The first study CDO will be designated CDO-A

Group Type: EXPERIMENTAL

Carbon Fiber Custom Dynamic Orthosis (CDO)

Intervention Type: 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.

CDO-B

The second study CDO will be designated CDO-B

Group Type: EXPERIMENTAL

Carbon Fiber Custom Dynamic Orthosis (CDO)

Intervention Type: 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.

Interventions

Carbon Fiber Custom Dynamic Orthosis (CDO)

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.

Intervention Type: DEVICE

Other Intervention Names

Ankle Foot Orthosis (AFO)

Eligibility Criteria

Inclusion Criteria

• 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)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Jason Wilken

Director of Collaborative Research and Development, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason M Wilken, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

202112331

Identifier Type: -

Identifier Source: org_study_id