Ankle Fracture > Custom Carbon Fiber Dynamic Orthosis (CDO)
~4 spots leftby Apr 2026

Custom Dynamic Orthoses for Osteoarthritis and Ankle Fracture

(PRMRP-FPA2 Trial)

Recruiting in Palo Alto (17 mi)
Overseen byJason M Wilken, PT, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of Iowa
No Placebo Group

Trial Summary

What is the purpose of this trial?

The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. Research suggests that ankle arthritis develops after ankle fracture, in part, due to elevated forces on the cartilage. It is expected that carbon fiber braces can be designed to reduce forces in the ankle joint and thereby reduce the risk of developing arthritis following traumatic injury. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The proposed study will provide evidence that can be used by clinicians and researchers to design braces that most effectively reduce forces on ankle cartilage.

Eligibility Criteria

Inclusion Criteria

You have had a serious fracture in your lower leg within the past 5 years.
Ages: 18-65
Your broken bone has fully healed.
See 5 more

Exclusion 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 severe pain (rated higher than 6 out of 10) when walking.
See 10 more

Treatment Details

Interventions

  • Custom Carbon Fiber Dynamic Orthosis (CDO) (Custom Dynamic Orthoses)
Participant Groups
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.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
University of IowaIowa City, IA
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Who Is Running the Clinical Trial?

University of IowaLead Sponsor
Fabtech SystemsCollaborator
University of DelawareCollaborator
Bio-Mechanical CompositesCollaborator

References

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