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NCT06976801 · ClinicalTrials.gov registry record · NA
Tibial IMN Vs. Tibial Micromotion IMN
A NA study of Tibial Fracture, sponsored by University of Chicago.
- Recruiting
- Registry status
- NA
- Development phase
- 372
- Enrollment target
- 1
- Study location
NCT06976801 is a NA study of Tibial Fracture that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 372 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06976801, a NA study of Tibial Fracture, is actively recruiting participants, sponsored by University of Chicago.
- RECRUITING
- Registry status
- NA
- Development phase
- 372 participants
- Enrollment target
- 1
- Study location
Study Summary
Our null hypothesis is that micromotion tibial intramedullary fixation (IMFN) does not impact union or complication rates when compared to standard of care treatment with non-micromotion tibial nail fixation. There are no current or past randomized controlled trials comparing these fixation techniques to one another. There is good data supporting both the use of intramedullary fixation for tibial fractures alone, and in high-risk patient populations (open fractures, GSW tibial fractures). 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. With much of the limited existing literature on tibial nails being in very defined populations, without a strong comparison group there is no clear guidance on when the use of a micromotion device is indicated. Our approach to randomize our patients will reduce the bias that exists in the current literature and provide a robust spectrum of injuries to sub analyze and compare. Objectives Primary Objective Compare post-operative union rates in tibial shaft patients treated with 2 types of intramedullary rod fixation devices. Secondary Objective(s) Compare complication rates, patient reported outcomes, range of motion, pain and radiographic/sonographic outcomes in patients treated with tibial nails.
Conditions Studied
Interventions
- DEVICE Intramedullary tibial Nail
- DEVICE Intermedullary nail
Study Locations (1)
Illinois
- University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 372 participants |
| Start Date | 2025-07-01 |
| Est. Completion | 2030-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06976801
The ClinicalTrials.gov registry entry for NCT06976801 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 372 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Tibial Fracture appearing as the primary indexed condition, and to 2 interventions - of which Intramedullary tibial Nail is the first listed.
NCT06976801 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT06976801 about?
NCT06976801 is a clinical study titled "Tibial IMN Vs. Tibial Micromotion IMN". Our null hypothesis is that micromotion tibial intramedullary fixation (IMFN) does not impact union or complication rates when compared to standard of care treatment with non-micromotion tibial nail fixation. There are no current or past randomized controlled trials comparing these fixation techniqu...
What is the current status of trial NCT06976801?
This trial is currently recruiting. It is a NA study. The enrollment target is 372 participants. The study started on 2025-07-01. Estimated completion is 2030-12.
What conditions does trial NCT06976801 study?
This clinical trial studies the following conditions: Tibial Fracture.
What interventions are being tested in trial NCT06976801?
The interventions under investigation include: Intramedullary tibial Nail (DEVICE), Intermedullary nail (DEVICE).
Who is sponsoring clinical trial NCT06976801?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06976801 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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