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Pilot Study and Preliminary Results of Biodegradable Intramedullary Nailing of Forearm Fractures in Children
(1) Background: Diaphyseal forearm fractures are a common injury in children and adolescents. When operative treatment is needed, elastic stable intramedullary nailing (ESIN) is the most common surgical procedure. Although there is no clear evidence, hardware removal after fracture healing is perfor...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9140014/ https://www.ncbi.nlm.nih.gov/pubmed/35626931 http://dx.doi.org/10.3390/children9050754 |
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author | Roeder, Christoph Alves, Cristina Balslev-Clausen, Andreas Canavese, Federico Gercek, Erol Kassai, Tamás Klestil, Thomas Klingenberg, Louise Lutz, Nicolas Varga, Marcell Jozsa, Gergo Weinberg, Annelie Tüshaus, Ludger |
author_facet | Roeder, Christoph Alves, Cristina Balslev-Clausen, Andreas Canavese, Federico Gercek, Erol Kassai, Tamás Klestil, Thomas Klingenberg, Louise Lutz, Nicolas Varga, Marcell Jozsa, Gergo Weinberg, Annelie Tüshaus, Ludger |
author_sort | Roeder, Christoph |
collection | PubMed |
description | (1) Background: Diaphyseal forearm fractures are a common injury in children and adolescents. When operative treatment is needed, elastic stable intramedullary nailing (ESIN) is the most common surgical procedure. Although there is no clear evidence, hardware removal after fracture healing is performed in many patients. Often, the primary minimal invasive incision needs to be widened during implant removal. In order to decrease the burden of care of pediatric fractures, significant efforts were made to develop biodegradable implants, which make hardware removal unnecessary. Our study will conduct an observational trial on the clinical use of the Activa IM-Nail™ in forearm fractures in children between 3 and 13 years of age. The objective of this trial is to evaluate the risks and benefits of the Activa IM-Nail™. Among other objectives, the rate of refracture will be determined. (2) Methods: An international Europe-based, multicenter, prospective, single-arm, open-label study will be performed to ascertain the rate of refracture and to determine the subjective benefits of Activa IM-Nail™ for patients, parents and other caregivers. The study will include clinical follow-up including early post-operative complication, radiographs until bony healing and an additional follow-up after 1 year. At this stage, preliminary results and early complications on 76 patients are analyzed in this study and presented. (3) Results: As of April 2022, 76 patients were enrolled as per study protocol. There were 31 girls (40.8%) and 45 boys (59.2%). The mean age at the time of inclusion was 8.9 years (±2.4 years). The mean operation time was 58.9 ± 22.9 min (range, 15–119 min). The mean follow-up time was 8.9 ± 5.1 months (range, 0.2–18.6). Up to now, one refracture has occurred in one child falling from a height of about one meter 7 months after index surgery (1/76; 1.3%). (4) Conclusion: The research project assesses the safety and effectiveness of Activa IM-Nails™ as part of the surgical treatment of dislocated forearm fractures in children in the context of a PMCF study. The use of Activa IM-Nails™ with regard to various objectives, including postoperative complications and refracture rate, seems to be equal to the standard titan ESIN procedure compared to the literature. Preliminary results are encouraging and are made available. |
format | Online Article Text |
id | pubmed-9140014 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-91400142022-05-28 Pilot Study and Preliminary Results of Biodegradable Intramedullary Nailing of Forearm Fractures in Children Roeder, Christoph Alves, Cristina Balslev-Clausen, Andreas Canavese, Federico Gercek, Erol Kassai, Tamás Klestil, Thomas Klingenberg, Louise Lutz, Nicolas Varga, Marcell Jozsa, Gergo Weinberg, Annelie Tüshaus, Ludger Children (Basel) Article (1) Background: Diaphyseal forearm fractures are a common injury in children and adolescents. When operative treatment is needed, elastic stable intramedullary nailing (ESIN) is the most common surgical procedure. Although there is no clear evidence, hardware removal after fracture healing is performed in many patients. Often, the primary minimal invasive incision needs to be widened during implant removal. In order to decrease the burden of care of pediatric fractures, significant efforts were made to develop biodegradable implants, which make hardware removal unnecessary. Our study will conduct an observational trial on the clinical use of the Activa IM-Nail™ in forearm fractures in children between 3 and 13 years of age. The objective of this trial is to evaluate the risks and benefits of the Activa IM-Nail™. Among other objectives, the rate of refracture will be determined. (2) Methods: An international Europe-based, multicenter, prospective, single-arm, open-label study will be performed to ascertain the rate of refracture and to determine the subjective benefits of Activa IM-Nail™ for patients, parents and other caregivers. The study will include clinical follow-up including early post-operative complication, radiographs until bony healing and an additional follow-up after 1 year. At this stage, preliminary results and early complications on 76 patients are analyzed in this study and presented. (3) Results: As of April 2022, 76 patients were enrolled as per study protocol. There were 31 girls (40.8%) and 45 boys (59.2%). The mean age at the time of inclusion was 8.9 years (±2.4 years). The mean operation time was 58.9 ± 22.9 min (range, 15–119 min). The mean follow-up time was 8.9 ± 5.1 months (range, 0.2–18.6). Up to now, one refracture has occurred in one child falling from a height of about one meter 7 months after index surgery (1/76; 1.3%). (4) Conclusion: The research project assesses the safety and effectiveness of Activa IM-Nails™ as part of the surgical treatment of dislocated forearm fractures in children in the context of a PMCF study. The use of Activa IM-Nails™ with regard to various objectives, including postoperative complications and refracture rate, seems to be equal to the standard titan ESIN procedure compared to the literature. Preliminary results are encouraging and are made available. MDPI 2022-05-20 /pmc/articles/PMC9140014/ /pubmed/35626931 http://dx.doi.org/10.3390/children9050754 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Roeder, Christoph Alves, Cristina Balslev-Clausen, Andreas Canavese, Federico Gercek, Erol Kassai, Tamás Klestil, Thomas Klingenberg, Louise Lutz, Nicolas Varga, Marcell Jozsa, Gergo Weinberg, Annelie Tüshaus, Ludger Pilot Study and Preliminary Results of Biodegradable Intramedullary Nailing of Forearm Fractures in Children |
title | Pilot Study and Preliminary Results of Biodegradable Intramedullary Nailing of Forearm Fractures in Children |
title_full | Pilot Study and Preliminary Results of Biodegradable Intramedullary Nailing of Forearm Fractures in Children |
title_fullStr | Pilot Study and Preliminary Results of Biodegradable Intramedullary Nailing of Forearm Fractures in Children |
title_full_unstemmed | Pilot Study and Preliminary Results of Biodegradable Intramedullary Nailing of Forearm Fractures in Children |
title_short | Pilot Study and Preliminary Results of Biodegradable Intramedullary Nailing of Forearm Fractures in Children |
title_sort | pilot study and preliminary results of biodegradable intramedullary nailing of forearm fractures in children |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9140014/ https://www.ncbi.nlm.nih.gov/pubmed/35626931 http://dx.doi.org/10.3390/children9050754 |
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