Carbon Fiber Custom Dynamic Orthosis (CDO) for Post-Traumatic Osteoarthritis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Iowa, Iowa City, IA
Post-Traumatic Osteoarthritis+3 More
Carbon Fiber Custom Dynamic Orthosis (CDO) - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

Carbon fiber custom dynamic orthoses (CDOs) consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that stores and returns energy during gait, and a carbon fiber foot plate that supports the foot and allows bending of the posterior strut. The proximal cuff is a primary interface between the patient and the CDO and may influence comfort, preference, limb mechanics and loading, and effective stiffness of the CDO. The important role of the proximal cuff has not been examined. The purpose of this study is to determine the effects of CDO proximal cuff design on patient reported outcomes, limb mechanics and loading, and CDO mechanical characteristics.

Eligible Conditions

  • Post-Traumatic Osteoarthritis
  • Healthy Subjects (HS)
  • Lower Limb Injuries

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Post-Traumatic Osteoarthritis

Study Objectives

7 Primary · 4 Secondary · Reporting Duration: Baseline

Baseline
Ankle Range of Motion
Center of Pressure Velocity Magnitude
Center of Pressure Velocity Timing
Medial Gastrocnemius Muscle Activity
Modified Socket Comfort Score (Comfort and Smoothness)
Numerical Pain Rating Scale
PROMIS Patient Reported Outcomes for Pain Interference
PROMIS Patient Reported Outcomes for Physical Function
Participant Device Preference
Peak Ankle Moment
Peak Ankle Power
Peroneus Longus Muscle Activity
Plantar Force
Semi-Structured Interview
Soleus Muscle Activity
Tibialis Anterior Muscle Activity

Trial Safety

Safety Progress

1 of 3

Other trials for Post-Traumatic Osteoarthritis

Trial Design

5 Treatment Groups

NoCDO
1 of 5
CUFF-B
1 of 5
CUFF-C
1 of 5
CUFF-A
1 of 5
CUFF-D
1 of 5
Active Control
Experimental Treatment

34 Total Participants · 5 Treatment Groups

Primary Treatment: Carbon Fiber Custom Dynamic Orthosis (CDO) · No Placebo Group · N/A

CUFF-B
Device
Experimental Group · 1 Intervention: Carbon Fiber Custom Dynamic Orthosis (CDO) · Intervention Types: Device
CUFF-C
Device
Experimental Group · 1 Intervention: Carbon Fiber Custom Dynamic Orthosis (CDO) · Intervention Types: Device
CUFF-A
Device
Experimental Group · 1 Intervention: Carbon Fiber Custom Dynamic Orthosis (CDO) · Intervention Types: Device
CUFF-D
Device
Experimental Group · 1 Intervention: Carbon Fiber Custom Dynamic Orthosis (CDO) · Intervention Types: Device
NoCDONoIntervention Group · 1 Intervention: NoCDO · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline

Trial Background

Prof. Jason Wilken, Director of Collaborative Research and Development, Associate Professor of Physical Therapy and Rehabilitation Science
Principal Investigator
University of Iowa
Closest Location: University of Iowa · Iowa City, IA
Photo of University of Iowa  1Photo of University of Iowa  2Photo of University of Iowa  3
1993First Recorded Clinical Trial
1 TrialsResearching Post-Traumatic Osteoarthritis
447 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a diagnosis of unilateral ankle PTOA.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.