Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
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
_version_ 1784714995532038144
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
work_keys_str_mv AT roederchristoph pilotstudyandpreliminaryresultsofbiodegradableintramedullarynailingofforearmfracturesinchildren
AT alvescristina pilotstudyandpreliminaryresultsofbiodegradableintramedullarynailingofforearmfracturesinchildren
AT balslevclausenandreas pilotstudyandpreliminaryresultsofbiodegradableintramedullarynailingofforearmfracturesinchildren
AT canavesefederico pilotstudyandpreliminaryresultsofbiodegradableintramedullarynailingofforearmfracturesinchildren
AT gercekerol pilotstudyandpreliminaryresultsofbiodegradableintramedullarynailingofforearmfracturesinchildren
AT kassaitamas pilotstudyandpreliminaryresultsofbiodegradableintramedullarynailingofforearmfracturesinchildren
AT klestilthomas pilotstudyandpreliminaryresultsofbiodegradableintramedullarynailingofforearmfracturesinchildren
AT klingenberglouise pilotstudyandpreliminaryresultsofbiodegradableintramedullarynailingofforearmfracturesinchildren
AT lutznicolas pilotstudyandpreliminaryresultsofbiodegradableintramedullarynailingofforearmfracturesinchildren
AT vargamarcell pilotstudyandpreliminaryresultsofbiodegradableintramedullarynailingofforearmfracturesinchildren
AT jozsagergo pilotstudyandpreliminaryresultsofbiodegradableintramedullarynailingofforearmfracturesinchildren
AT weinbergannelie pilotstudyandpreliminaryresultsofbiodegradableintramedullarynailingofforearmfracturesinchildren
AT tushausludger pilotstudyandpreliminaryresultsofbiodegradableintramedullarynailingofforearmfracturesinchildren