Antibiotic Coated Nail for Preventing Infection in Broken Bones

Recruiting at 16 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

Trial Summary

What is the purpose of this trial?

This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.

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 data supports the effectiveness of the treatment Antibiotic Coated Nail for preventing infection in broken bones?

Research shows that antibiotic-coated nails are effective in treating bone infections, especially in cases where the bone is not healing properly. They release high levels of antibiotics directly at the site, helping to control infection and support bone healing, with studies reporting a high success rate in infection control and bone healing. ^{1 2 3 4 5}

How is the antibiotic-coated intramedullary nail treatment different from other treatments for preventing infections in broken bones?

The antibiotic-coated intramedullary nail is unique because it releases high concentrations of antibiotics directly at the site of the fracture, providing both infection control and bone stability, which is not typically achieved with standard treatments. This local delivery minimizes systemic side effects and enhances the healing process in cases of infected fractures or non-unions. ^{1 2 3 4 5}

Research Team

Joseph Hsu, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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.

I am 18 years old or older.

Exclusion Criteria

I cannot speak English or Spanish.

I am under 18 years old.

Pregnant and lactating women

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Antibiotic coated nails: Rationale, development, indications and outcomes. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Antibiotic Cement-Coated Interlocked Intramedullary Nails for the Treatment of Infected Nonunion After Intramedullary Nailing. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Coated nails: is their use supported by the literature? [2023]

4. Korea (South) 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. [2020]

5. Netherlands 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. [2022]