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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
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 moreSecondary study objectives
Ankle Range of Motion
Four Square Step Test (4SST)
Modified Socket Comfort Score (Comfort)
+5 moreOther study objectives
Center of pressure velocity magnitude
Center of pressure velocity timing
Medial Gastrocnemius Muscle Activity (Electromyography)
+5 moreAwards & 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
467 Previous Clinical Trials
893,471 Total Patients Enrolled
Jason M Wilken, PT, PhDPrincipal InvestigatorUniversity of Iowa
11 Previous Clinical Trials
348 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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