Cargando…

The Wire Study—a protocol for a multi-stage feasibility study evaluating K-wire fixation of hand fractures in the UK

BACKGROUND: Hand fractures are common and sometimes require surgery to restore function. Placement of Kirschner wires (K-wires) is the most common form of surgical fixation. After placement, a key decision is whether to bury the end of a K-wire or leave it protruding from the skin (exposed). A recen...

Descripción completa

Detalles Bibliográficos
Autores principales: Wormald, Justin Conrad Rosen, Mikhail, Mark Medhat, Rodrigues, Jeremy Neil, Gardiner, Sonya, Pezas, Theodore, Lloyd-Hughes, Hawys, Issa, Fadi, Jain, Abhilash, Gardiner, Matthew David
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8212482/
https://www.ncbi.nlm.nih.gov/pubmed/34140031
http://dx.doi.org/10.1186/s40814-021-00858-4
_version_ 1783709647919644672
author Wormald, Justin Conrad Rosen
Mikhail, Mark Medhat
Rodrigues, Jeremy Neil
Gardiner, Sonya
Pezas, Theodore
Lloyd-Hughes, Hawys
Issa, Fadi
Jain, Abhilash
Gardiner, Matthew David
author_facet Wormald, Justin Conrad Rosen
Mikhail, Mark Medhat
Rodrigues, Jeremy Neil
Gardiner, Sonya
Pezas, Theodore
Lloyd-Hughes, Hawys
Issa, Fadi
Jain, Abhilash
Gardiner, Matthew David
author_sort Wormald, Justin Conrad Rosen
collection PubMed
description BACKGROUND: Hand fractures are common and sometimes require surgery to restore function. Placement of Kirschner wires (K-wires) is the most common form of surgical fixation. After placement, a key decision is whether to bury the end of a K-wire or leave it protruding from the skin (exposed). A recent systematic review found no evidence to support either approach and a national clinician and surgeon survey demonstrated further uncertainty. We aim to determine the design of a definitive randomised controlled trial assessing the cost and clinical effectiveness of buried versus exposed Kirschner wires for adults with metacarpal or phalangeal fractures. METHODS: We will employ three methodologies: a national service evaluation of current clinical practice, patient and surgeon focus groups and a consensus meeting to finalise the protocol for a randomised controlled trial. For the service evaluation, all outcomes will be summarised using descriptive statistics overall and split by group (buried versus exposed K-wires). Information collected in the patient focus groups will be analysed thematically. The surgeon consensus meeting will address each part of the design in turn and through discussion agree a final protocol. DISCUSSION: The study may be monitored, or audited in accordance with the current approved protocol, Good Clinical Practice (GCP), relevant regulations and standard operating procedures. The Chief Investigator will submit and, where necessary, obtain approval from the above parties for all substantial amendments to the original approved documents. A feasibility study report will be published by the Wire Study Steering committee. Additional members of the steering group and citable collaborators will be listed within the manuscript and their roles identified.
format Online
Article
Text
id pubmed-8212482
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-82124822021-06-22 The Wire Study—a protocol for a multi-stage feasibility study evaluating K-wire fixation of hand fractures in the UK Wormald, Justin Conrad Rosen Mikhail, Mark Medhat Rodrigues, Jeremy Neil Gardiner, Sonya Pezas, Theodore Lloyd-Hughes, Hawys Issa, Fadi Jain, Abhilash Gardiner, Matthew David Pilot Feasibility Stud Study Protocol BACKGROUND: Hand fractures are common and sometimes require surgery to restore function. Placement of Kirschner wires (K-wires) is the most common form of surgical fixation. After placement, a key decision is whether to bury the end of a K-wire or leave it protruding from the skin (exposed). A recent systematic review found no evidence to support either approach and a national clinician and surgeon survey demonstrated further uncertainty. We aim to determine the design of a definitive randomised controlled trial assessing the cost and clinical effectiveness of buried versus exposed Kirschner wires for adults with metacarpal or phalangeal fractures. METHODS: We will employ three methodologies: a national service evaluation of current clinical practice, patient and surgeon focus groups and a consensus meeting to finalise the protocol for a randomised controlled trial. For the service evaluation, all outcomes will be summarised using descriptive statistics overall and split by group (buried versus exposed K-wires). Information collected in the patient focus groups will be analysed thematically. The surgeon consensus meeting will address each part of the design in turn and through discussion agree a final protocol. DISCUSSION: The study may be monitored, or audited in accordance with the current approved protocol, Good Clinical Practice (GCP), relevant regulations and standard operating procedures. The Chief Investigator will submit and, where necessary, obtain approval from the above parties for all substantial amendments to the original approved documents. A feasibility study report will be published by the Wire Study Steering committee. Additional members of the steering group and citable collaborators will be listed within the manuscript and their roles identified. BioMed Central 2021-06-17 /pmc/articles/PMC8212482/ /pubmed/34140031 http://dx.doi.org/10.1186/s40814-021-00858-4 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Wormald, Justin Conrad Rosen
Mikhail, Mark Medhat
Rodrigues, Jeremy Neil
Gardiner, Sonya
Pezas, Theodore
Lloyd-Hughes, Hawys
Issa, Fadi
Jain, Abhilash
Gardiner, Matthew David
The Wire Study—a protocol for a multi-stage feasibility study evaluating K-wire fixation of hand fractures in the UK
title The Wire Study—a protocol for a multi-stage feasibility study evaluating K-wire fixation of hand fractures in the UK
title_full The Wire Study—a protocol for a multi-stage feasibility study evaluating K-wire fixation of hand fractures in the UK
title_fullStr The Wire Study—a protocol for a multi-stage feasibility study evaluating K-wire fixation of hand fractures in the UK
title_full_unstemmed The Wire Study—a protocol for a multi-stage feasibility study evaluating K-wire fixation of hand fractures in the UK
title_short The Wire Study—a protocol for a multi-stage feasibility study evaluating K-wire fixation of hand fractures in the UK
title_sort wire study—a protocol for a multi-stage feasibility study evaluating k-wire fixation of hand fractures in the uk
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8212482/
https://www.ncbi.nlm.nih.gov/pubmed/34140031
http://dx.doi.org/10.1186/s40814-021-00858-4
work_keys_str_mv AT wormaldjustinconradrosen thewirestudyaprotocolforamultistagefeasibilitystudyevaluatingkwirefixationofhandfracturesintheuk
AT mikhailmarkmedhat thewirestudyaprotocolforamultistagefeasibilitystudyevaluatingkwirefixationofhandfracturesintheuk
AT rodriguesjeremyneil thewirestudyaprotocolforamultistagefeasibilitystudyevaluatingkwirefixationofhandfracturesintheuk
AT gardinersonya thewirestudyaprotocolforamultistagefeasibilitystudyevaluatingkwirefixationofhandfracturesintheuk
AT pezastheodore thewirestudyaprotocolforamultistagefeasibilitystudyevaluatingkwirefixationofhandfracturesintheuk
AT lloydhugheshawys thewirestudyaprotocolforamultistagefeasibilitystudyevaluatingkwirefixationofhandfracturesintheuk
AT issafadi thewirestudyaprotocolforamultistagefeasibilitystudyevaluatingkwirefixationofhandfracturesintheuk
AT jainabhilash thewirestudyaprotocolforamultistagefeasibilitystudyevaluatingkwirefixationofhandfracturesintheuk
AT gardinermatthewdavid thewirestudyaprotocolforamultistagefeasibilitystudyevaluatingkwirefixationofhandfracturesintheuk
AT wormaldjustinconradrosen wirestudyaprotocolforamultistagefeasibilitystudyevaluatingkwirefixationofhandfracturesintheuk
AT mikhailmarkmedhat wirestudyaprotocolforamultistagefeasibilitystudyevaluatingkwirefixationofhandfracturesintheuk
AT rodriguesjeremyneil wirestudyaprotocolforamultistagefeasibilitystudyevaluatingkwirefixationofhandfracturesintheuk
AT gardinersonya wirestudyaprotocolforamultistagefeasibilitystudyevaluatingkwirefixationofhandfracturesintheuk
AT pezastheodore wirestudyaprotocolforamultistagefeasibilitystudyevaluatingkwirefixationofhandfracturesintheuk
AT lloydhugheshawys wirestudyaprotocolforamultistagefeasibilitystudyevaluatingkwirefixationofhandfracturesintheuk
AT issafadi wirestudyaprotocolforamultistagefeasibilitystudyevaluatingkwirefixationofhandfracturesintheuk
AT jainabhilash wirestudyaprotocolforamultistagefeasibilitystudyevaluatingkwirefixationofhandfracturesintheuk
AT gardinermatthewdavid wirestudyaprotocolforamultistagefeasibilitystudyevaluatingkwirefixationofhandfracturesintheuk