Comparing the standard tibial intramedullary nail with a micromotion tibial nail for unstable tibial fractures.
Official title: Prospective, Randomized-control Trial Comparing Standard Intramedullary Tibial Fixation With Micromotion Tibial Intramedullary Fixation
Run by University of Chicago · NCT06976801 · Data updated 2026-11-12
This trial will test whether a micromotion tibial nail helps adults with unstable tibial fractures heal faster and have fewer complications than a standard tibial nail.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 372 (estimated) |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | December 2029 |
| Study ends | December 2030 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT06976801 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) with unstable tibial shaft fractures recommended for surgical intramedullary fixation who are ambulatory, present within four weeks of injury, have no active infection and no major immune or rheumatic disease, and can attend follow-up visits.
✕Probably not a fit
Patients with stable fracture patterns, delayed presentation (>4 weeks), non-ambulatory status, active infection, need for additional fixation strategies, significant immune or rheumatic disease, or inability to follow study procedures (including non-English speakers or those on workers' compensation) are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with unstable tibial shaft fractures will receive either a micromotion-design intramedullary nail or a standard intramedullary tibial nail and be followed after surgery. The study will collect radiographic union data, complication rates, and functional outcome measures through scheduled clinic visits and post-discharge contact. Perioperative details, infections, nonunion, and return-to-function metrics will be recorded and compared between the two groups. The trial is conducted at the University of Chicago using the institution's resources to maintain follow-up and perform a robust analysis.
Why it matters
Potential benefit: If successful, the micromotion nail could increase bone healing rates and reduce complications, improving recovery and function for patients with unstable tibial fractures.
How similar studies have gone: Intramedullary nailing is a well-established effective treatment for tibial fractures, but no randomized trials have directly compared micromotion-design nails to standard nails, so this head-to-head comparison is relatively untested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Chicago
Chicago, Illinois, United States Recruiting
Study contacts
- Study coordinator: Brianna Fram, MD
- Email: bfram@uchicago.edu
- Phone: 773-834-3531
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.