NCT06679049 · University of Alabama at Birmingham
Comparison of Healing Measures Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing
What this study is about
The primary purpose of this study is to perform a high-quality randomly assigned 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.
View original scientific description
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.
Interventions
PROCEDURE
micromotion intramedullary nail cohort
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal tibial interlocking screw
PROCEDURE
standard intramedullary nail cohort
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal interlocking screw
Primary outcome measures
The difference in radiographic union
Time frame: 12,18 and 24 weeks between micromotion intramedullary fixation and standard IMN post operatively
bridging callus, minimum three cortices bridged
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations