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Orthosis

Carbon Fiber Braces for Osteoarthritis (PRMRP FPA CT Trial)

N/A
Waitlist Available
Led By Jason M Wilken, PT, PhD
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

PRMRP FPA CT Trial Summary

This trial will test how well carbon fiber braces reduce forces on the ankle cartilage to prevent arthritis.

Eligible Conditions
  • Osteoarthritis
  • Ankle Fracture

PRMRP FPA CT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Joint Contact Stress Exposure (Model estimated)
Numerical Pain Rating Scale
Participant Device Preference
+8 more
Secondary outcome measures
Ankle Range of Motion
Four Square Step Test (4SST)
Modified Socket Comfort Score (Comfort)
+5 more
Other outcome measures
Center of pressure velocity magnitude
Center of pressure velocity timing
Medial Gastrocnemius Muscle Activity (Electromyography)
+5 more

PRMRP FPA CT Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: CDO-BExperimental Treatment1 Intervention
The second study CDO will be designated CDO-B
Group II: CDO-AExperimental Treatment1 Intervention
The first study CDO will be designated CDO-A
Group III: NoCDOActive Control1 Intervention
Participants will be evaluated without a CDO
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carbon Fiber Custom Dynamic Orthosis (CDO)
2021
N/A
~10

Find a Location

Who is running the clinical trial?

University of IowaLead Sponsor
446 Previous Clinical Trials
879,502 Total Patients Enrolled
Jason M Wilken, PT, PhDPrincipal InvestigatorUniversity of Iowa
11 Previous Clinical Trials
348 Total Patients Enrolled

Media Library

Carbon Fiber Custom Dynamic Orthosis (CDO) (Orthosis) Clinical Trial Eligibility Overview. Trial Name: NCT05209347 — N/A
Carbon Fiber Custom Dynamic Orthosis (CDO) (Orthosis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05209347 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for potential participants to join this experiment?

"As per the records on clinicaltrials.gov, this medical trial has stopped enrolling patients as of May 25th 2022 - even though it was initially listed on August 1st 2022. Nevertheless, there are 648 other trials that are currently recruiting participants right now."

Answered by AI

What is the eligibility criteria for participating in this trial?

"This medical trial seeks 20 participants aged 18-65 with a unilateral fracture of the tibial pilon that has completely healed. Furthermore, applicants must meet various requirements such as being able to read and write in English, having shoe sizes between women's 8 - 13.5 or men's 6.5 - 12; also they should be capable of walking without an assistive device for 50 feet at slow/moderate speed. Moreover, their contact stress levels will be assessed after visit one is completed."

Answered by AI

Is the enrollment of persons over sixty a requisite for this research trial?

"This trial has established that the age range for its participants should span between 18 and 65. If one does not meet these criteria, there are 33 trials available for those under 18 or 616 studies open to individuals above this threshold."

Answered by AI

Who else is applying?

What state do they live in?
Nebraska
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Custom Dynamic Orthoses to Reduce Articular Contact Stress
Jason Wilken 2024. "Custom Dynamic Orthoses to Reduce Articular Contact Stress". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05209347.
~0 spots leftby Dec 2025
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