ArticleTherapeutics and clinical risk management2016
Patients' safety: is there a systemic release of gentamicin by gentamicin-coated tibia nails in clinical use?
Article in Therapeutics and clinical risk management, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- Potential side effects of antibacterial coatings in orthopaedic implants: A systematic review of clinical studies.Frontiers in bioengineering and biotechnology · 2023Pooled it
- Gentamicin-Coated Tibia Nail in Fractures and Nonunion to Reduce Fracture-Related Infections: A Systematic Review.Molecules (Basel, Switzerland) · 2020Pooled it
- Distinct Basal Gut Microbiota Profiles Are Associated with Strain-Specific Lung Responses toBiology · 2026Article
- Two-Year Follow-Up Shows Gentamicin-Coated Tibial Nails Reduce Infection Rates in Open Tibial Fractures.Antibiotics (Basel, Switzerland) · 2025Article
- Current Strategies in the Prevention and Management of Infection in Open Fractures.Journal of orthopaedics and sports medicine · 2025Article
- [Intramedullary nailing of coated and uncoated nails in infected tibial pseudarthrosis : Results of a retrospective examination of 56 patients].Unfallchirurgie (Heidelberg, Germany) · 2024Article
- Clinical Application of Antibacterial Hydrogel and Coating in Orthopaedic and Traumatology Surgery.Gels (Basel, Switzerland) · 2021Article
- Treatment of severely open tibial fractures, non-unions, and fracture-related infections with a gentamicin-coated tibial nail-clinical outcomes including quality of life analysis and psychological ICD-10-based symptom rating.Journal of orthopaedic surgery and research · 2021Article
- Nanotheranostics: A Possible Solution for Drug-ResistantNanomaterials (Basel, Switzerland) · 2021Review
- Uncoated vs. Antibiotic-Coated Tibia Nail in Open Diaphyseal Tibial Fracture (42 according to AO Classification): A Single Center Experience.BioMed research international · 2021Article
- Commercially available antibiotic-laden PMMA-covered locking nails for the treatment of fracture-related infections - A retrospective case analysis of 10 cases.Journal of bone and joint infection · 2019Article
- Coatings as the useful drug delivery system for the prevention of implant-related infections.Journal of orthopaedic surgery and research · 2018Review
- Initial peri- and postoperative antibiotic treatment of infected nonunions: results from 212 consecutive patients after mean follow-up of 34 months.Therapeutics and clinical risk management · 2018Article
- CORR InsightsClinical orthopaedics and related research · 2017Article
- [Susceptibility to infections and behavior of stainless steel : Comparison with titanium implants in traumatology].Der Unfallchirurg · 2017Review
- Preliminary Outcomes of a Staged Percutaneous Retrograde Prefabricated Gentamicin-coated Intramedullary Nail to Manage Complications after Ankle Fusion through Tibial Bone Transport.Strategies in trauma and limb reconstructionArticle
Corrections and comments
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Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionOsteitis is one of the most serious complications in orthopedic surgery. Expert Tibia Nail (ETN) PROtect™ coated with a biodegradable layer of gentamicin-laden polymer was developed for prophylaxis of osteomyelitis. In systemic administration, gentamicin has only a small therapeutic index and serious side effects; it is potentially nephrotoxic as well as ototoxic. It is not yet known if relevant gentamicin concentrations are released into the systemic circulation after implantation of gentamicin-coated nails. In order to evaluate the patients' risks profiles and increase patient safety, we measured gentamicin levels in pre- and postoperative serum samples of patients undergoing implantation of ETN PROtect.
methodsTwenty-five patients who received ETN PROtect between March 2012 and August 2014 were included in this study. Collection of blood samples occurred before the operation, at weeks 1-4, 3 and 6 months, and up to 1 year after the implantation. Measurement of gentamicin levels in serum samples was performed at the central laboratory of Heidelberg University Hospital. Additionally, laboratory parameters, C-reactive protein, leukocyte number, urea and creatinine concentrations were analyzed in routine controls before and after operating and assessed for systemic side effects.
resultsOver the course of this prospective observational study, we were able to determine that gentamicin-coated nails do not release gentamicin into the systemic circulation above the lowest detectable level of 0.2 mg/dL. There were slight increases in the mean inflammation and renal retention markers, but no gentamicin-associated side effects could be linked to implantation. Furthermore, no allergic reactions could be detected during our study.
conclusionOur findings suggest that there is no relevant release of gentamicin into the systemic circulation causing a systemic effect, and serious side effects due to gentamicin-coated tibia nails should not be feared. Postoperative monitoring of renal function does not seem necessary because of the implantation of ETN PROtect.
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