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Custom Dynamic Orthoses to Reduce Articular Contact Stress

NCT05209347 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-01-15

No results posted yet for this study

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

  • Ankle Fractures
  • Post-traumatic Osteoarthritis
  • Osteoarthritis Ankle

Interventions

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.

Sponsors & Collaborators

  • 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
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2025-12-31
Completion
2025-12-31
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 NCT05209347 on ClinicalTrials.gov