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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
454 Previous Clinical Trials
882,038 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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