NCT05209347

Custom Dynamic Orthoses to Reduce Articular Contact Stress

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-01-26
• Last updated: 2026-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study