RecruitingNot ApplicableNCT06976801

Tibial IMN Vs. Tibial Micromotion IMN

Prospective, Randomized-control Trial Comparing Standard Intramedullary Tibial Fixation With Micromotion Tibial Intramedullary Fixation


Sponsor

University of Chicago

Enrollment

372 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Intermedullary nail and a medical device called Intramedullary tibial Nail for people with tibial fracture. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIntramedullary tibial Nail

Subjects will receive the micromotion MicroMotion Intramedullary tibial Nail

DEVICEIntermedullary nail

The non-micromotion intermedullary nail


Locations(1)

University of Chicago

Chicago, Illinois, United States

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NCT06976801