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

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European Journal of Orthopaedic Surgery & Traumatology Aims and scope Submit manuscript

Abstract

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.

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Authors and Affiliations

  1. Limb Reconstruction and Bone Infection Service, The Royal London Hospital, Barts Health NHS Trust, Whitechapel Road, London, E1 1FR, UK

    Kavi H. Patel, Prabu Balasubramanian, Alexios D. Iliadis, Nima Heidari & Alex Vris

  2. KAT General Hospital, Nikis 2, 145 61, Kifisia, Greece

    Athanasios Galanis

Authors
  1. Kavi H. Patel
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  2. Athanasios Galanis
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  3. Prabu Balasubramanian
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  4. Alexios D. Iliadis
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  5. Nima Heidari
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Correspondence to Kavi H. Patel.

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All authors declare we have no conflicts of interest and no funds/grants were received for this study.

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Informed consent was not required as no patients were contacted for this study and all data were anonymised. The study was registered with the hospital’s research department.

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Patel, K.H., Galanis, A., Balasubramanian, P. et al. A major trauma centre experience with gentamicin-coated tibial intramedullary nails (ETN PROtect™) in acute primary open fracture fixation and complex revision surgery. Eur J Orthop Surg Traumatol 33, 1745–1750 (2023). https://doi.org/10.1007/s00590-022-03338-4

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  • DOI: https://doi.org/10.1007/s00590-022-03338-4

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