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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
No Placebo-Only Group

Summary

This trial tests special carbon fiber braces on adults with severe ankle fractures to see if they can reduce joint stress and prevent arthritis. The braces are expected to lessen pressure on the ankle, helping to avoid arthritis after an injury.

Eligible Conditions
  • Ankle Fracture
  • Osteoarthritis

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
470 Previous Clinical Trials
894,780 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
~0 spots leftby Dec 2025
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