NCT06679049NARecruiting
Comparison of Healing Measures Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing
University of Alabama at Birmingham
Start Date
4/30/2025
Completion Date
1/31/2027
Summary
The primary purpose of this study is to perform a high-quality randomized control trial comparing intramedullary tibial nail fixation with standard design nails to a micromotion tibial nail device, to evaluate the rates of union and post-operative outcomes.
Eligibility Criteria
Age Range: 18 years to 85 years
Inclusion Criteria:
* Age 18 - 85 years
* Stable Tibial fracture recommended for surgical intervention
Exclusion Criteria:
* Patients not meeting inclusion criteria
* Unstable fracture patterns e.g. those needing a secondary intervention - masquelet/cement spacer)
* 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 achieve infection or wound at the surgical site
* Any previous ligament or fracture surgery on the index site
* Inflammatory rheumatic disease or other rheumatic disease-
* Immune compromised patients (hepatitis, HIV, etc.)
* Unwilling or unable to participate or follow study protocol
Interventions
PROCEDURE
micromotion intramedullary nail cohort
PROCEDURE
standard intramedullary nail cohort
Conditions
Tibial Fractures
Locations
University of Alabama at Birmingham Main Hospital
Birmingham, Alabama 35294
United States