Cargando…

Clinical validation of the ‘C-arm rotational view (CARV)’: study protocol of a prospective randomised controlled trial

INTRODUCTION: Rotational malalignment occurs in up to 30% of cases after intramedullary nailing of tibial shaft fractures. The aim of this study is to assess the clinical feasibility of a newly introduced standardised intraoperative fluoroscopy protocol coined ‘C-arm rotational view (CARV)’ in order...

Descripción completa

Detalles Bibliográficos
Autores principales: Bleeker, Nils Jan, Doornberg, Job N, ten Duis, Kaj, El Moumni, Mostafa, Jaarsma, Ruurd L, IJpma, Frank F A
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10668275/
https://www.ncbi.nlm.nih.gov/pubmed/37993156
http://dx.doi.org/10.1136/bmjopen-2022-064802
_version_ 1785149100029640704
author Bleeker, Nils Jan
Doornberg, Job N
ten Duis, Kaj
El Moumni, Mostafa
Jaarsma, Ruurd L
IJpma, Frank F A
author_facet Bleeker, Nils Jan
Doornberg, Job N
ten Duis, Kaj
El Moumni, Mostafa
Jaarsma, Ruurd L
IJpma, Frank F A
author_sort Bleeker, Nils Jan
collection PubMed
description INTRODUCTION: Rotational malalignment occurs in up to 30% of cases after intramedullary nailing of tibial shaft fractures. The aim of this study is to assess the clinical feasibility of a newly introduced standardised intraoperative fluoroscopy protocol coined ‘C-arm rotational view (CARV)’ in order to reduce the risk of rotational malalignment during intramedullary nailing of tibial shaft fractures. The CARV includes predefined fluoroscopy landmark views of the uninjured side to obtain correct alignment of the injured side with use of the rotation of the C-arm. METHODS AND ANALYSIS: This randomised controlled trial will be conducted in a level 1 trauma centre. Adult patients with an open or closed tibial fracture, eligible for intramedullary nailing, will be enrolled in the study. The interventional group will undergo intramedullary nailing guided by the CARV protocol to obtain accurate alignment. The control group is treated according to current clinical practice, in which alignment control of the tibia is based on clinical estimation of the treating surgeon. The primary endpoint is defined as the degree of rotation measured on low-dose postoperative CT scans. ETHICS AND DISSEMINATION: The study protocol will be performed in line with local ethical guidelines and the Declaration of Helsinki. The results of this trial will be disseminated in a peer-reviewed manuscript. Future patients are likely to benefit from this trial as it aims to provide a clinically feasible and easy-to-use standardised fluoroscopy protocol to reduce the risk for rotational malalignment during intramedullary nailing of tibial shaft fractures. TRIAL REGISTRATION NUMBER: NCT05459038.
format Online
Article
Text
id pubmed-10668275
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-106682752023-11-22 Clinical validation of the ‘C-arm rotational view (CARV)’: study protocol of a prospective randomised controlled trial Bleeker, Nils Jan Doornberg, Job N ten Duis, Kaj El Moumni, Mostafa Jaarsma, Ruurd L IJpma, Frank F A BMJ Open Surgery INTRODUCTION: Rotational malalignment occurs in up to 30% of cases after intramedullary nailing of tibial shaft fractures. The aim of this study is to assess the clinical feasibility of a newly introduced standardised intraoperative fluoroscopy protocol coined ‘C-arm rotational view (CARV)’ in order to reduce the risk of rotational malalignment during intramedullary nailing of tibial shaft fractures. The CARV includes predefined fluoroscopy landmark views of the uninjured side to obtain correct alignment of the injured side with use of the rotation of the C-arm. METHODS AND ANALYSIS: This randomised controlled trial will be conducted in a level 1 trauma centre. Adult patients with an open or closed tibial fracture, eligible for intramedullary nailing, will be enrolled in the study. The interventional group will undergo intramedullary nailing guided by the CARV protocol to obtain accurate alignment. The control group is treated according to current clinical practice, in which alignment control of the tibia is based on clinical estimation of the treating surgeon. The primary endpoint is defined as the degree of rotation measured on low-dose postoperative CT scans. ETHICS AND DISSEMINATION: The study protocol will be performed in line with local ethical guidelines and the Declaration of Helsinki. The results of this trial will be disseminated in a peer-reviewed manuscript. Future patients are likely to benefit from this trial as it aims to provide a clinically feasible and easy-to-use standardised fluoroscopy protocol to reduce the risk for rotational malalignment during intramedullary nailing of tibial shaft fractures. TRIAL REGISTRATION NUMBER: NCT05459038. BMJ Publishing Group 2023-11-22 /pmc/articles/PMC10668275/ /pubmed/37993156 http://dx.doi.org/10.1136/bmjopen-2022-064802 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Surgery
Bleeker, Nils Jan
Doornberg, Job N
ten Duis, Kaj
El Moumni, Mostafa
Jaarsma, Ruurd L
IJpma, Frank F A
Clinical validation of the ‘C-arm rotational view (CARV)’: study protocol of a prospective randomised controlled trial
title Clinical validation of the ‘C-arm rotational view (CARV)’: study protocol of a prospective randomised controlled trial
title_full Clinical validation of the ‘C-arm rotational view (CARV)’: study protocol of a prospective randomised controlled trial
title_fullStr Clinical validation of the ‘C-arm rotational view (CARV)’: study protocol of a prospective randomised controlled trial
title_full_unstemmed Clinical validation of the ‘C-arm rotational view (CARV)’: study protocol of a prospective randomised controlled trial
title_short Clinical validation of the ‘C-arm rotational view (CARV)’: study protocol of a prospective randomised controlled trial
title_sort clinical validation of the ‘c-arm rotational view (carv)’: study protocol of a prospective randomised controlled trial
topic Surgery
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10668275/
https://www.ncbi.nlm.nih.gov/pubmed/37993156
http://dx.doi.org/10.1136/bmjopen-2022-064802
work_keys_str_mv AT bleekernilsjan clinicalvalidationofthecarmrotationalviewcarvstudyprotocolofaprospectiverandomisedcontrolledtrial
AT doornbergjobn clinicalvalidationofthecarmrotationalviewcarvstudyprotocolofaprospectiverandomisedcontrolledtrial
AT tenduiskaj clinicalvalidationofthecarmrotationalviewcarvstudyprotocolofaprospectiverandomisedcontrolledtrial
AT elmoumnimostafa clinicalvalidationofthecarmrotationalviewcarvstudyprotocolofaprospectiverandomisedcontrolledtrial
AT jaarsmaruurdl clinicalvalidationofthecarmrotationalviewcarvstudyprotocolofaprospectiverandomisedcontrolledtrial
AT ijpmafrankfa clinicalvalidationofthecarmrotationalviewcarvstudyprotocolofaprospectiverandomisedcontrolledtrial