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NCT04562896 · ClinicalTrials.gov registry record · NA
Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress
A NA study, sponsored by University of Iowa.
- Completed
- Registry status
- NA
- Development phase
- 22
- Enrollment target
NCT04562896: Completed NA study, sponsored by University of Iowa.
NCT04562896 is a NA study that has completed, run by University of Iowa. The registered enrollment target is 22 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04562896, a NA study, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- NA
- Development phase
- 22 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Joint contact stress time exposure (MPA-s/gait cycle) was estimated using a participant specific musculoskeletal model. Peak joint contact stress time exposure (MPA-s/gait cycle) acting on the tibia during the gait cycle were reported. Lower peak contact stress time exposure is considered a better outcome.
Interventions
- DEVICE Custom Carbon Fiber Dynamic Orthosis (CDO)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-01-08 |
| Est. Completion | 2023-10-05 |
| Phase | NA |
What the finished NCT04562896 record still lists
NCT04562896 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Custom Carbon Fiber Dynamic Orthosis (CDO) is the first listed.
NCT04562896 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04562896 about?
NCT04562896 is a clinical study titled "Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress". 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 t...
What is the current status of trial NCT04562896?
This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2020-01-08. Estimated completion is 2023-10-05.
What interventions are being tested in trial NCT04562896?
The interventions under investigation include: Custom Carbon Fiber Dynamic Orthosis (CDO) (DEVICE).
Who is sponsoring clinical trial NCT04562896?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04562896's enrollment target sits among peer trials
22 1756th of 2000 higher than 239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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