Antibiotic Coated Nail for Preventing Infection in Broken Bones

Recruiting at 17 trial locations

Overseen By Natasha Howard

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Allergy to vancomycin, gentamicin, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: During index hospitalization

484 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an antibiotic-coated nail can better prevent infections in people with open tibia fractures compared to a standard nail. Researchers aim to determine if adding antibiotics to the nail reduces infections after surgery. The trial involves two treatment plans: one group receives the antibiotic-coated nail, while the other receives the standard nail. People with open tibia fractures requiring an intramedullary nail for bone repair may be suitable candidates, particularly those with severe breaks that pierce the skin (Type II or III open fractures). As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for these treatments?

Research has shown that antibiotic-coated intramedullary nails are generally safe for humans. Coated with antibiotics such as vancomycin and gentamicin, these nails effectively control infections. One study managed infections without recurrence, indicating the treatment's reliability in preventing infections.

Furthermore, studies have not identified any significant side effects from using these nails. They have successfully treated fractures and cases where broken bones did not heal properly. Participants in these studies did not experience major negative reactions to the antibiotics in the coating.

Overall, these findings suggest that antibiotic-coated nails are well-tolerated and safe for treating bone infections. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the antibiotic coated intramedullary nail because it offers a new way to prevent infections in broken bones. Unlike the standard treatment that uses a plain intramedullary nail, this innovative nail is coated with antibiotics like vancomycin and gentamicin. This coating actively fights bacteria, potentially reducing the risk of infection right at the site of the fracture. By directly delivering antibiotics where they're needed most, this approach could offer better protection against infections compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for preventing infection in broken bones?

Research has shown that antibiotic-coated nails, a treatment under study in this trial, effectively prevent infections in broken bones. Studies have found a high success rate of 93.3% in stopping infections and 90.0% in aiding proper bone healing. These nails are coated with antibiotics like vancomycin and gentamicin, which target infections directly at the break site without causing side effects elsewhere in the body. This method has successfully treated infections in long bones, such as the femur and tibia, promoting proper healing. Overall, this treatment has demonstrated strong results in both preventing infections and promoting bone healing. Participants in this trial may receive either the antibiotic-coated nails or standard intramedullary nails to compare their effectiveness. ^{1 2 5 6 7}

Who Is on the Research Team?

Joseph Hsu, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults with a type II or III open tibia fracture needing a nail implant to fix the bone. Participants must be able to follow up for a year and speak English or Spanish. It's not for those under 18, allergic to vancomycin/gentamicin, pregnant/lactating women, prisoners, or unable to commit.

Inclusion Criteria

I have a severe open fracture in my shin that needs surgery with a metal rod.

Exclusion Criteria

I cannot speak English or Spanish.

I am under 18 years old.

Pregnant and lactating women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a prophylactic antibiotic coated intramedullary nail or a traditional standard of care intramedullary nail during definitive fixation

During index hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data capture at baseline, 6 weeks, 3 months, 6 months, and 12 months

12 months

Visits at baseline, 6 weeks, 3 months, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Antibiotic coated intramedullary Nail
• Standard Intramedullary Nail

Trial Overview The study compares two treatments: one uses an antibiotic-coated nail designed to prevent infection after surgery; the other uses a standard intramedullary nail without antibiotics. Patients are randomly assigned to either group.

How Is the Trial Designed?

Group I: Intramedullary Nail Active Control 1 Intervention

Traditional standard of care intramedullary (IM) nail

Group II: Antibiotic Coated Intramedullary Nail Active Control 1 Intervention

Intramedullary Nail coated with 2 grams of vancomycin and 560 mg gentamicin liquid.

Antibiotic coated intramedullary Nail is already approved in India for the following indications:

Approved in India as Antibiotic-coated nail for:

• Infected nonunion and chronic osteomyelitis of long bones

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

The interlocking antibiotic cement-coated nail technique effectively eradicated infection and achieved fracture healing in 85.4% of the 41 patients treated for infected nonunion after intramedullary nailing.

Even among the 6 patients who initially had persistent infections, 5 eventually healed with further treatment, demonstrating the overall efficacy of this approach in managing complex cases of nonunion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiotic Cement-Coated Interlocked Intramedullary Nails for the Treatment of Infected Nonunion After Intramedullary Nailing. Zalikha, AK., Sayeed, Z., Stine, SA., et al.[2023]

Antimicrobial-coated intramedullary nails show a high infection eradication rate of 90% and a bone consolidation rate of 85.5% in treating infected non-unions of the femur and tibia, based on a review of 22 publications involving 506 cases.

Despite the promising results, most studies were retrospective case series with low scientific quality, highlighting the need for randomized controlled trials to better assess the efficacy and safety of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual and commercially available antimicrobial coatings for intramedullary nails for the treatment of infected long bone non-unions - a systematic review. Walter, N., Rupp, M., Krückel, J., et al.[2022]

Antibiotic-coated intramedullary nails are effective for treating long-bone infections, particularly in cases of fractures and nonunions, by providing localized antibiotic delivery with minimal systemic toxicity.

These nails are made using antibiotic-impregnated cement around a metal core, and while case series show good outcomes in terms of bone union and infection control, further research is needed to optimize their use and determine safe weight limits for load-bearing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coated nails: is their use supported by the literature? Liu, JZ., Crist, BD.[2023]

A 79-year-old woman with a femoral subtrochanteric fracture and subsequent osteomyelitis was successfully treated using an antibiotic cement-coated tibial intramedullary nail, which helped achieve bone union and resolve the infection.

The use of antibiotic cement-coated nails provides a dual benefit of maintaining high local antibiotic concentrations while stabilizing the bone, making it an effective treatment option for osteomyelitis and nonunion in cases with limited intramedullary space.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Proximal Femur Osteomyelitis Occurred after Proximal Femoral Nail Antirotation Fixation, with Antibiotic Cement-coated Tibia Intramedullary Nail: A Case Report. Noh, JH., Koh, SJ., Lee, KH.[2020]

Antibiotic-coated intramedullary nails are an effective treatment for unstable diaphyseal infections associated with fractures or non-unions, as they provide local high concentrations of antibiotics while maintaining stability.

These commercially fabricated implants offer advantages over hand-made versions, combining effective infection control with the mechanical support needed for proper healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiotic coated nails: Rationale, development, indications and outcomes. Kalbas, Y., Klingebiel, F., Pape, HC.[2023]

Citations

1. nature.com nature.com/articles/s41598-025-00934-2

Effectiveness of antibiotic-impregnated bone cement in ... AIBC not only prevents infection recurrence but also supports robust bone healing and functional recovery.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10496935/

Results of Antibiotic-Impregnated Cement/Polymer-Coated ... The procedure demonstrated a high success rate in controlling infections (93.3%) and achieving bone union (90.0%).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9219703/

Efficacy of Infection Eradication in Antibiotic Cement ... This study suggests that ACCINs are effective in the treatment of FRIs, infected long bone nonunions, and infected ankle and knee arthrodeses.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S002013832300164X

Antibiotic cement-coated rigid locked nails in infected ... Using antibiotic-cement-coated rigid nails has proved helpful in treating infected nonunions of the femur and the tibia, achieving high rates of bone union and ...

5. journals.lww.com journals.lww.com/aoam/fulltext/2023/22040/outcome_of_intramedullary_nail_coated_with.5.aspx

Outcome of Intramedullary Nail Coated with Antibiotic ... Antibiotic cement-coated nails are an effective method in local control of infection in Chr OM without any systemic side effect.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10775937/

Outcome of Intramedullary Nail Coated with Antibiotic ... Infection was controlled in all the cases (two cases required repeat antibiotic-coated nailing), and there was no incidence of relapse in any case. The control ...

7. link.springer.com link.springer.com/article/10.1007/s00590-023-03668-x

Antibiotic impregnated cement coated intramedullary nail ... A 70–100% bony union rate with eradication of infection has been reported in over 41 clinical studies [2]. ACCIN has also been shown as ...