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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two surgical techniques for fixing broken shinbones (tibial fractures). One group will receive a standard intramedullary nail, while the other will use a micromotion intramedullary nail. The study will compare how well and fast the bones heal. It seeks participants with a stable tibial fracture who need surgery. Those with a recent leg fracture and a doctor's recommendation for surgery might be suitable candidates. The goal is to determine which method leads to better recovery and healing. As an unphased trial, this study offers a unique opportunity to contribute to medical knowledge and potentially benefit future patients with similar injuries.

Do I have to stop taking my current medications for the trial?

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 nailing techniques are safe for tibial fracture treatment?

Studies have shown that the Micromotion Intramedullary Nail is generally safe for treating tibial fractures. One initial study reported no safety issues with this new type of nail, indicating it is well-tolerated by patients. Another study found a high success rate in healing fractures, demonstrating its effectiveness without major side effects.

Research shows that the Standard Intramedullary Nail is a common and reliable method for treating long bone fractures. It typically has low infection rates and causes minimal scarring. Most studies report successful fracture healing in a reasonable time, suggesting it is safe for patients.

Both treatments appear safe and effective based on past studies, with no major safety concerns noted. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Micromotion Intramedullary Nail because it introduces a potentially more effective stabilization technique for tibial fractures. Unlike standard intramedullary nailing, which primarily focuses on rigid fixation, the Micromotion nail is designed to allow slight movement at the fracture site. This micromotion is thought to promote better bone healing by stimulating biological processes, which could lead to faster recovery times and stronger bone repair. This innovative approach may offer a significant advancement over traditional methods, which do not incorporate this dynamic healing stimulation.

What evidence suggests that this trial's treatments could be effective for tibial fractures?

Studies have shown that standard intramedullary nails are the preferred choice for fixing broken shinbones (tibial fractures). They enable patients to begin weight-bearing soon after surgery, which accelerates healing. Research indicates that these nails result in a high rate of bone healing, with about 90% of cases recovering successfully in around six months. Patients often experience less damage to the surrounding soft tissue compared to other methods. This trial tests both micromotion and standard intramedullary nails in separate treatment arms. The standard version already has a strong history of success. ^{6 7 8 9 10}

Who Is on the Research Team?

Joseph Johnson, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11539009/

Impact of Surgical Timing on Fracture Healing in Tibial ... This comprehensive review aims to evaluate the impact of surgical timing on fracture healing outcomes in tibial shaft fractures treated with IMN.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2768276525000446

Outcomes of Suprapatellar Intramedullary Nail Fixation ... It offers immediate weight-bearing capability, enhanced stability, and reduced soft tissue damage due to less surgical dissection when compared with plates [5].

3. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-09162-1

Comparison of suprapatellar and infrapatellar intramedullary ... Intermedullary nailing (IMN) is the gold standard for the surgical treatment of extra-articular tibial fractures.

4. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2025.1473038/full

Poor radiological outcomes and associated factors among ... Intramedullary nailing is now the standard treatment for long bone fractures, resulting in low infection rates, tiny scars, excellent fracture ...

5. jccpractice.com jccpractice.com/article/outcomes-of-intramedullary-nailing-in-tibial-shaft-fractures-experience-from-a-low-resource-economically-constrained-setting-912/

Outcomes of Intramedullary Nailing in Tibial Shaft Fractures This study demonstrated high rates of radiological union (90%) and excellent functional recovery in majority of patients within 6-month follow- ...

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

Treatment of diaphyseal tibial fracture nonunion with an ... In this case series, we present our experience with treating tibial shaft fracture nonunion with an intramedullary micromotion nail. Keywords.

7. 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 ...

8. 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 ...

9. 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 conclusion, this pilot study found no concerns with safety or efficacy associated with micromotion tibial nailing. Clinical outcomes with ...

10. 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 ...