A major trauma centre experience with gentamicin-coated tibial intramedullary nails (ETN PROtect™) in acute primary open fracture fixation and complex revision surgery.

Purpose: Fracture-related infections (FRI) following intramedullary nailing for tibial shaft fractures remain challenging to treat with associated high patient morbidity and health care costs. Recently, antibiotic-coated nails have been introduced as a strategy to reduce implant related infection rates in high-risk patients. We present the largest single-centre case series on ETN PROtect® outcomes reporting on fracture union, infection rates and treatment complications.

Methods: Fifty-six adult patients underwent surgery with ETN PROtect® between 01/09/17 and 31/12/20. Indications consisted of acute open fractures and complex revision cases (previous FRI, non-union surgery and re-fracture) with a mean of three prior surgical interventions. We report on patient demographics, union rates and deep infection. Minimum follow-up was one year.

Results: One (1.8%) patient developed a deep surgical infection and associated non-union requiring further surgery. In addition, we identified three cases (5.4%) of aseptic non-union following facture treatment with ETN PROtect®. Of the five patients who underwent staged complex revision surgery for established FRI with ETN PROtect®, all had treatment failure with ongoing symptoms of deep infection requiring implant removal and further treatment.

Conclusion: Use of the ETN PROtect® nail in high-risk patients (open fractures and those initially treated with external fixation) and in those patients with aseptic non-unions, demonstrates promising outcomes in the prevention of implant-related infection. In our limited series we have failed to observe any benefit over uncoated nails, when used in treating cases of previously established FRI/osteomyelitis and would therefore advise caution in their use, especially in view of the high cost.