Intramedullary Nailing for Tibial Fracture

Overseen By Joseph Johnson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Unstable fractures, Non-ambulatory, Immune compromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 24 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Joseph Johnson, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for adults aged 18-85 with stable tibial fractures that require surgery. It's not suitable for those who don't meet the age requirement or have conditions that make them unsuitable for surgical intervention.

Inclusion Criteria

I have a stable fracture in my shinbone that needs surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo intramedullary tibial nail fixation with either standard design nails or a micromotion tibial nail device

24 weeks

Regular follow-up visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, including radiographic union and complication rates

1 year

Visits at 12, 18, and 24 weeks, and 1 year post-operatively

Treatment Details

Interventions

• Micromotion Intramedullary Nail
• Standard Intramedullary Nail

Trial Overview The study compares two methods of fixing tibial fractures: one uses a standard intramedullary nail, and the other uses a micromotion nail designed to improve healing. Participants are randomly assigned to either group.

Participant Groups

Group I: Standard Cohort Experimental Treatment 1 Intervention

use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal interlocking screw

Group II: Micromotion Cohort Experimental Treatment 1 Intervention

use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal tibial interlocking screw

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+