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Tibial IMN Vs. Tibial Micromotion IMN

NCT06976801 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2025-10-09

No results posted yet for this 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

  • Tibial Fracture

Interventions

DEVICE

Intramedullary tibial Nail

Subjects will receive the micromotion MicroMotion Intramedullary tibial Nail

DEVICE

Intermedullary nail

The non-micromotion intermedullary nail

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2029-12-31
Completion
2030-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06976801 on ClinicalTrials.gov