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NCT05204485 · ClinicalTrials.gov registry record · NA
Diabetic Fibular Nail Study
A NA study, sponsored by University of Chicago.
- Terminated
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT05204485: Clinical Trial NA study, sponsored by University of Chicago.
NCT05204485 is a NA study that was terminated before completion, run by University of Chicago. The registered enrollment target is 2 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05204485, a NA study, was terminated before completion, sponsored by University of Chicago.
- TERMINATED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study Summary
Our null hypothesis is that fibular intramedullary fixation (IMFN) does not impact complication rates when compared to standard of care treatment with open reduction and internal fixation (ORIF). There are no current or past RCTs comparing these fixation techniques to one another in diabetic patients. There is good data supporting both the use of intramedullary fixation for fibular fractures alone, and in high-risk patient populations (elderly, and diabetics). However, the effectiveness of these methods with respect to each other has never been investigated. The knowledge gained will allow us to potentially influence and adapt protocols to treat this patient population. Additionally, resources available at our institution provide a supportive framework with which to maintain contact with patients after hospital discharge. These key factors will allow us to perform a robust analysis of this population, to include outcomes measures of function and complications.
Primary Outcome
The difference in overall composite complication rate between Fibular intramedullary fixation and ORIF
Interventions
- PROCEDURE Fibular intramedullary nail
- PROCEDURE Open reduction and internal fixation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2024-01-19 |
| Phase | NA |
Why NCT05204485 stopped before completion
NCT05204485 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Fibular intramedullary nail is the first listed.
NCT05204485 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05204485 about?
NCT05204485 is a clinical study titled "Diabetic Fibular Nail Study". Our null hypothesis is that fibular intramedullary fixation (IMFN) does not impact complication rates when compared to standard of care treatment with open reduction and internal fixation (ORIF). There are no current or past RCTs comparing these fixation techniques to one another in diabetic patient...
What is the current status of trial NCT05204485?
This trial is currently terminated. It is a NA study. The enrollment target is 2 participants. The study started on 2022-03-07. Estimated completion is 2024-01-19.
What interventions are being tested in trial NCT05204485?
The interventions under investigation include: Fibular intramedullary nail (PROCEDURE), Open reduction and internal fixation (PROCEDURE).
Who is sponsoring clinical trial NCT05204485?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05204485's enrollment target sits among peer trials
2 1997th of 2000 the lowest 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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