Comparison of Healing Measures Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing
Comparison of Healing Measures in Diaphyseal Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing
University of Alabama at Birmingham
100 participants
Apr 30, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria11
- Age 18 - 85 years
- Stable Tibial fracture recommended for surgical intervention
- 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
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Interventions
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal tibial interlocking screw
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal interlocking screw
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06679049