Status:
RECRUITING
Tibial IMN Vs. Tibial Micromotion IMN
Lead Sponsor:
University of Chicago
Conditions:
Tibial Fracture
Eligibility:
All Genders
18+ years
Phase:
NA
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 f...
Detailed Description
The advent of the intramedullary nail (IMN) has revolutionized the treatment of tibial shaft fractures due to its percutaneous route of insertion, frequent facilitation of immediate weightbearing, and...
Eligibility Criteria
Inclusion
- Age 18 or older
- Unstable tibial fracture recommended for surgical intervention
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT06976801
Start Date
July 1 2025
End Date
December 1 2030
Last Update
October 9 2025
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637