The use of gentamicin-coated nails in the tibia: preliminary results of a prospective study

Abstract

BackgroundThe use of antibiotic-coated implants may reduce the rate of infection and facilitate fracture healing after surgical treatment of tibial shaft fractures. A new biodegradable gentamicin-loaded coating of an implant (UTN PROtect®) was CE-certified in August 2005. In this prospective, non-randomized case series, we investigated the clinical, laboratory and radiological outcomes of 21 patients who underwent surgical treatment in closed or open tibial fractures, as well as revisions with the UTN PROtect® gentamicin-coated intramedullary nail.MethodsOf 21 patients (13 men, 8 women), 19 completed the 6-month follow-up. The study population included patients with complex tibial fractures and late revision cases. Clinical outcomes comprised adverse events, including infections and the SF-36 physical score. Laboratory outcomes, including C-reactive protein and leukocyte count as inflammatory markers, haemoglobin and serum gentamicin, were measured at baseline and up to 6 months post operatively. Radiographic assessments of fracture healing and weight-bearing capacity were determined at 5 weeks, 3 and 6 months after surgery.ResultsNo implant-related infections occurred; one patient had superficial wound healing problems. Mean C-reactive protein levels remained below 5 mg/L throughout the study, with a peak at 4–7 days after surgery (4.4 mg/L; range 0.5–16.1 mg/L). Leukocyte counts and haemoglobin levels did not vary over time during the study. The mean SF-36 physical score at 6 months was 42.6 (range 19.4–56.7). Radiographic union defined as three or four bridged cortices was achieved in 11 patients (58%) after 6 months. The remaining eight patients showed partial fracture healing with one or two bridged cortices. Additionally, 13 patients (68%) demonstrated full weight-bearing capacity after 6 months.ConclusionsThe use of the UTN PROtect® intramedullary nail was associated with good clinical, laboratory and radiological outcomes after 6 months. These preliminary results support the use of gentamicin-coated implants as a new potential treatment option for the prevention of infection in trauma patients and in revision cases.Level of EvidenceLevel II.

Antimicrobial technology in orthopedic and spinal implants

“…In a rabbit model, Alt et al [16] found that the gentamicin-HA composite provided a statistically significant reduction in infection rate when compared to uncoated total joint replacements. In patient trials, gentamicin-coated implants have displayed promising preliminary results ( Figure 1) [17][18][19][20] . Limitations of antibiotic coatings include the use of fixed, predetermined antibiotics; limited duration of drug elution; and the risk of developing drug resistance [21] .…”

Antibacterial PHAs coating for titanium implants

“…Metal-based drug eluting systems have received little attention in the literature in comparison to polymer-based systems. So far, only intramedullary nails with a PDLLA coating containing gentamicin were placed on the market [14]. For example, metal implants such as plates and wires have been coated with a polymer matrix layer loaded with a microbial antibiotic, while others have studied different therapeutic agents including triclosan and chlorhexidine (CHX) [15,16,17].…”

Does Vitamin E-blended UHMWPE Prevent Biofilm Formation?

“…Examples include passive and active antimicrobial coatings [4,9,19], surface modifications [10], and bioabsorbable sleeves that contain antimicrobials [16]. Data suggest that implant materials alone, such as black silicon and silicon nitride, may have the ability to prevent bacterial attachment or eradicate bacteria that come in contact with the material [7,10].…”