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From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices

NCT06352788 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-01-15

No results posted yet for this study

Summary

This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury.

Conditions

  • Foot Injury

Interventions

DEVICE

Modular Carbon Fiber Custom Dynamic Orthosis (CDO)

The CDO will use a modular design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.

DEVICE

Mono Carbon Fiber Custom Dynamic Orthosis (CDO)

The CDO will use a mono design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Navy Medical Center San Diego

    collaborator FED

  • Minneapolis Veterans Affairs Medical Center

    collaborator FED

  • Johns Hopkins University

    collaborator OTHER

  • Jason Wilken

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-02
Primary Completion
2027-08-31
Completion
2028-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT06352788 on ClinicalTrials.gov