Actively Recruiting
Comparison of Healing Measures in Diaphyseal Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing
Led by University of Alabama at Birmingham · Updated on 2026-05-14
100
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized control trial to compare two types of intramedullary tibial nail fixation devices used to treat diaphyseal tibial fractures. The study aims to evaluate differences in bone healing rates and post-operative outcomes between a standard design nail and a micromotion tibial nail device. This trial is sponsored by the University of Alabama at Birmingham and involves adult patients with stable tibial fractures recommended for surgery. Participants will be randomly assigned to receive either the micromotion intramedullary nail or the standard intramedullary nail. Both treatments involve the use of at least two distal interlocking screws and at least one proximal tibial interlocking screw to stabilize the fracture. The study will monitor healing and complications over time, with follow-up assessments scheduled at 12, 18, and 24 weeks after surgery. During the study, participants will undergo radiographic evaluations to measure bone union at specified weeks post-operation. Researchers will also track complication rates for one year after surgery to assess safety and outcomes. The total study duration allows for thorough observation of healing progress and post-operative recovery in patients aged 18 to 85 years with tibial fractures.
CONDITIONS
Brief Title
Comparison of Healing Measures Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 85 years
- Stable tibial fracture recommended for surgical intervention
You will not qualify if you...
- Patients not meeting inclusion criteria
- Unstable fracture patterns requiring secondary intervention such as masquelet or cement spacer
- Previously non-ambulatory patients
- Delayed fracture presentation over 4 weeks
- Fractures needing additional fixation strategies for stability
- Active infection or wound at the surgical site
- Previous ligament or fracture surgery on the affected leg
- Inflammatory or other rheumatic diseases
- Immune compromised patients (e.g., hepatitis, HIV)
- Unwilling or unable to participate or follow study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week or until hospital discharge
Participants undergo surgical fixation of tibial fractures using either micromotion intramedullary nailing or standard intramedullary nailing.
1 surgical procedure visit and hospital stay
Duration - 24 weeks
Participants have regular follow-up visits to monitor fracture healing and assess for complications over the first 24 weeks.
Visits at approximately 12, 18, and 24 weeks post-operation
Duration - Up to 1 year post-operation
Participants are monitored for complication rates up to 1 year after surgery.
Periodic visits or assessments up to 1 year
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham Main Hospital
Birmingham, Alabama, United States, 35294
Actively Recruiting
Research Team
J
Joseph Johnson, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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