CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
Custom Carbon Fiber Dynamic Orthosis (CDO)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04562896
NCT04562896N/ACompleted

Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress

University of Iowa·interventional·Posted Sep 24, 2020·Updated Jan 30, 2026

In Brief

A clinical study evaluating Custom Carbon Fiber Dynamic Orthosis (CDO) for Ankle Fractures and 2 related conditions. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 24, 2020
Enrollment StartJan 8, 2020
Primary CompletionOct 5, 2023
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 5.8 years ago

Interventions

Custom Carbon Fiber Dynamic Orthosis (CDO)device

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.