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The use of gentamicin-coated nails in the tibia: preliminary results of a prospective study
BACKGROUND: The 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, no...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer-Verlag
2011
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3175046/ https://www.ncbi.nlm.nih.gov/pubmed/21617934 http://dx.doi.org/10.1007/s00402-011-1321-6 |
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author | Fuchs, Thomas Stange, Richard Schmidmaier, Gerhard Raschke, Michael J. |
author_facet | Fuchs, Thomas Stange, Richard Schmidmaier, Gerhard Raschke, Michael J. |
author_sort | Fuchs, Thomas |
collection | PubMed |
description | BACKGROUND: The 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. METHODS: Of 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. RESULTS: No 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. CONCLUSIONS: The 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 EVIDENCE: Level II. |
format | Online Article Text |
id | pubmed-3175046 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2011 |
publisher | Springer-Verlag |
record_format | MEDLINE/PubMed |
spelling | pubmed-31750462011-09-26 The use of gentamicin-coated nails in the tibia: preliminary results of a prospective study Fuchs, Thomas Stange, Richard Schmidmaier, Gerhard Raschke, Michael J. Arch Orthop Trauma Surg Trauma Surgery BACKGROUND: The 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. METHODS: Of 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. RESULTS: No 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. CONCLUSIONS: The 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 EVIDENCE: Level II. Springer-Verlag 2011-05-24 2011-10 /pmc/articles/PMC3175046/ /pubmed/21617934 http://dx.doi.org/10.1007/s00402-011-1321-6 Text en © Springer-Verlag 2011 |
spellingShingle | Trauma Surgery Fuchs, Thomas Stange, Richard Schmidmaier, Gerhard Raschke, Michael J. The use of gentamicin-coated nails in the tibia: preliminary results of a prospective study |
title | The use of gentamicin-coated nails in the tibia: preliminary results of a prospective study |
title_full | The use of gentamicin-coated nails in the tibia: preliminary results of a prospective study |
title_fullStr | The use of gentamicin-coated nails in the tibia: preliminary results of a prospective study |
title_full_unstemmed | The use of gentamicin-coated nails in the tibia: preliminary results of a prospective study |
title_short | The use of gentamicin-coated nails in the tibia: preliminary results of a prospective study |
title_sort | use of gentamicin-coated nails in the tibia: preliminary results of a prospective study |
topic | Trauma Surgery |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3175046/ https://www.ncbi.nlm.nih.gov/pubmed/21617934 http://dx.doi.org/10.1007/s00402-011-1321-6 |
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