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Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress

NCT04562896 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-01-30

Study results available
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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
  • Post-traumatic Osteoarthritis
  • Osteoarthritis Ankle

Interventions

DEVICE

Custom Carbon Fiber Dynamic Orthosis (CDO)

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.

Sponsors & Collaborators

  • University of Delaware

    collaborator OTHER

  • Bio-Mechanical Composites

    collaborator UNKNOWN

  • Fabtech Systems

    collaborator UNKNOWN

  • University of Iowa

    lead OTHER

Principal Investigators

  • Jason M Wilken, PT, PhD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-08
Primary Completion
2023-10-05
Completion
2023-10-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04562896 on ClinicalTrials.gov