| NCT ID | NCT06976801 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Chicago |
| Condition | Tibial Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 372 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 372 participants in total. It began in 2025-07-01 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06976801 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tibial Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06976801 currently recruiting?
Yes, NCT06976801 is actively recruiting participants. Contact the research team at anthony.christiano@bsd.uchicago.edu for enrollment information.
Where is the NCT06976801 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06976801 clinical trial?
NCT06976801 is sponsored by University of Chicago. The trial plans to enroll 372 participants.