Intramedullary Fixation Devices for Tibial Fractures

Overseen By Douglas Zhang, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Non-ambulatory, Delayed presentation, Infections, Rheumatic, Immune compromised, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

372 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods for fixing tibial fractures using rods inside the bone, known as intramedullary fixation devices. The researchers aim to determine which method promotes better bone healing and causes fewer post-surgery complications. Participants must have an unstable tibial fracture requiring surgery. The study will also assess patients' feelings, range of motion, and any pain experienced after treatment. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance future treatment options for tibial fractures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these intramedullary fixation devices are safe for tibial fractures?

Research has shown that micromotion tibial intramedullary fixation devices are safe and effective. One study found that these devices can accelerate bone healing, particularly in high-risk patients. Another report showed a 94% success rate in treating new fractures, indicating that most patients healed well without major issues.

For non-micromotion tibial nail fixation, strong evidence supports its use for various tibial fractures, including severe cases like open fractures or gunshot wounds. These treatments are generally well-tolerated and have been successful in many instances.

Overall, both treatments are safe for humans and have strong evidence supporting their effectiveness in promoting bone healing without major complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the tibial intramedullary fixation techniques being explored because they promise to enhance healing in broken tibias. Unlike traditional methods that use rigid fixation, micromotion tibial intramedullary fixation allows for slight movements at the fracture site, which can stimulate bone healing and potentially lead to faster recovery. This technique might offer a less invasive option compared to the current standard, which often involves plates and screws that can be more intrusive. The non-micromotion tibial nail fixation, serving as a comparator, provides a benchmark to evaluate the benefits of micromotion, helping researchers determine whether this innovative approach can truly improve patient outcomes.

What evidence suggests that these intramedullary fixation devices are effective for tibial fractures?

Research has shown that a new method called micromotion tibial fixation, which participants in this trial may receive, might help broken shinbones heal faster than traditional methods. Early evidence from clinical trials and animal studies suggests that the gentle movement allowed by this method speeds up healing. A small study found it successfully healed 94% of new fractures. Another treatment option in this trial is non-micromotion tibial nail fixation, a traditional method already proven effective. Both methods aim to keep the bone stable, but micromotion fixation might offer additional benefits in some situations. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older with unstable tibial fractures that require surgery. It's not specified who can't join, but typically those with conditions affecting bone healing or unable to follow the study protocol might be excluded.

Inclusion Criteria

I am 18 years old or older.

I have a severe shinbone fracture that needs surgery.

Exclusion Criteria

Patients not meeting inclusion criteria (Stable fracture patterns)

Utilizing worker's compensation at the time of screening

Immune compromised patients (hepatitis, HIV, etc.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either micromotion tibial intramedullary fixation or non-micromotion tibial nail fixation

6 weeks

Regular follow-up visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of union rates and complications

6 months

Visits at 6 weeks, 6 months, and 1 year

Long-term Follow-up

Participants are monitored for long-term outcomes such as complication rates, patient-reported outcomes, and radiographic assessments

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Intermedullary Nail
• Intramedullary Tibial Nail

Trial Overview The trial compares two surgical techniques for fixing tibial fractures: a standard intramedullary nail and a micromotion variant. The goal is to see if there's any difference in how well bones heal and other outcomes like pain and range of motion.

How Is the Trial Designed?

Group I: micromotion tibial intramedullary fixation Experimental Treatment 1 Intervention

Subject will receive micromotion tibial intramedullary fixation

Group II: non-micromotion tibial nail fixation Active Control 1 Intervention

Subject will receive non-micromotion tibial nail fixation

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8558444/

Pilot study of micromotion nailing for mechanical ... The study objective was to prospectively assess clinical outcomes for a pilot cohort of tibial shaft fractures treated with a new tibial nailing system that ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06976801

NCT06976801 | Tibial IMN Vs. Tibial Micromotion IMN The primary purpose of this study is to perform a high-quality randomized control trial comparing intramedullary tibial nail fixation with standard design nails ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X25002401

Treatment of diaphyseal tibial fracture nonunion with an ... Early evidence from ovine studies and clinical trials has suggested that axial micromotion mediates faster tibial fracture healing compared to ...

4. boneandjoint.org.uk boneandjoint.org.uk/Article/10.1302/2633-1462.210.BJO-2021-0121.R1

Pilot study of micromotion nailing for mechanical stimulation of ... In this pilot study, mechanical stimulation through controlled micromotion fixation promoted faster healing, particularly in at-risk patients.

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/10225536251352559

Advancements in micromotion-based fixation systems for ... Clinical outcomes further validate its effectiveness, with Bastiani et al. reported a 94% success rate in 288 fresh fractures and an average ...