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Custom Dynamic Orthoses
Custom Dynamic Orthoses for Osteoarthritis and Ankle Fracture (PRMRP-FPA2 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-FPA2 Trial Summary
This trial will examine if carbon fiber braces can reduce forces on ankle cartilage to stop arthritis from developing after a fracture. The brace geometry will be varied to find the most effective design.
Eligible Conditions
- Ankle Fracture
- Osteoarthritis
PRMRP-FPA2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
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 Time Exposure (Model estimated)
Numerical Pain Rating Scale
Participant Device Preference
+8 moreSecondary outcome measures
Ankle Range of Motion
Four Square Step Test (4SST)
Modified Socket Comfort Score (Comfort and Smoothness)
+6 moreOther outcome measures
Center of pressure velocity magnitude
Center of pressure velocity timing
Medial Gastrocnemius Muscle Activity (Electromyography)
+5 morePRMRP-FPA2 Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: CDO-CExperimental Treatment1 Intervention
The third design variant will be designated CDO-C
Group II: CDO-BExperimental Treatment1 Intervention
The second design variant will be designated CDO-B
Group III: CDO-AExperimental Treatment1 Intervention
The first design variant will be designated CDO-A
Group IV: No DeviceActive Control1 Intervention
Participants will be evaluated without a CDO.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Custom Carbon Fiber Dynamic Orthosis (CDO)
2020
N/A
~30
Find a Location
Who is running the clinical trial?
Fabtech SystemsUNKNOWN
1 Previous Clinical Trials
20 Total Patients Enrolled
University of IowaLead Sponsor
446 Previous Clinical Trials
879,475 Total Patients Enrolled
University of DelawareOTHER
154 Previous Clinical Trials
25,184 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) is higher than 40.You have wounds on your calf that would make it difficult to wear the CDO device.You have had a serious fracture in your lower leg within the past 5 years.You have severe pain (rated higher than 6 out of 10) when walking.Your broken bone has fully healed.Your pain increases to a level of 3 out of 10 or higher during the testing.You have a condition that affects the function of the opposite side of your body, like your brain, muscles, or bones.You have broken bones caused by nerve damage or very weak bones.You need to use a special device to support your knee in order to do everyday activities.You have a medical or psychological condition that would prevent you from participating in the functional testing, like having a severe brain injury, stroke, or heart disease.You have previously broken a bone near the lower part of your leg on the side being studied.You are able to walk slowly or at a medium speed.
Research Study Groups:
This trial has the following groups:- Group 1: CDO-C
- Group 2: CDO-B
- Group 3: CDO-A
- Group 4: No Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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