Tibial IMN Vs. Tibial Micromotion IMN

Recruiting now · Not applicable

Conditions studied: Tibial Fracture

In brief

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.

Key facts

Study ID

NCT06976801

Run by

University of Chicago

People needed

372

Starts

2025-07-01

Expected to finish

2030-12-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or older
• Unstable tibial fracture recommended for surgical intervention

You may not qualify if…

• Patients not meeting inclusion criteria (Stable fracture patterns)
• Previously non-ambulatory patients
• Delayed presentation of fracture (>4 weeks)
• Fractures that the treating surgeon indicates requires additional fixation strategies to achieve stability
• Patients with an active infection or wound at the surgical site
• Utilizing worker's compensation at the time of screening
• Any previous ligament or fracture surgery on the index site
• Inflammatory rheumatic disease or other rheumatic disease
• Immune compromised patients (hepatitis, HIV, etc.)
• Non-English-speaking patients
• Unwilling or unable to participate or follow study protocol

Where it is running

• University of Chicago — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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