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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

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Conditions

Tibial Fractures

Locations

University of Alabama at Birmingham Main Hospital

Birmingham, Alabama 35294

United States