Recruiting

Micromotion vs. Standard

Sponsor:

University of Chicago

Code:

NCT06976801

Conditions

Tibial Fracture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intramedullary tibial Nail

Intermedullary nail

Study Details

Brief 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

Study ID

NCT06976801

Start date

Jul 1, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18 or older
2. Unstable tibial fracture recommended for surgical intervention

Exclusion Criteria:

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

Study Design

Enrollment

372 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: micromotion tibial intramedullary fixation

Subject will receive micromotion tibial intramedullary fixation

active comparator: non-micromotion tibial nail fixation

Subject will receive non-micromotion tibial nail fixation

Interventions

Intramedullary tibial Nail

Subjects will receive the micromotion MicroMotion Intramedullary tibial Nail

Intermedullary nail

The non-micromotion intermedullary nail

Primary outcome measure

  • Compare post-operative union rates [ Time Frame: six months ]

Central Contacts and Locations

Central contacts

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

Brianna Fram, MD

More Information

Sponsor

University of Chicago

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • Unstable tibial fracture
  • intramedullary nail
  • micromotion tibial nail fixation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-07-09.