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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...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2021
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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 |
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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 |
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