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Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial)
BACKGROUND: Syndesmotic injuries are common and their incidence is rising. In case of surgical fixation of the syndesmosis a metal syndesmotic screw is used most often. It is however unclear whether this screw needs to be removed routinely after the syndesmosis has healed. Traditionally the screw is...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5793393/ https://www.ncbi.nlm.nih.gov/pubmed/29386053 http://dx.doi.org/10.1186/s12891-018-1946-5 |
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author | Dingemans, S. A. Birnie, M. F. N. Sanders, F. R. K. van den Bekerom, M. P. J. Backes, M. van Beeck, E. Bloemers, F. W. van Dijkman, B. Flikweert, E. Haverkamp, D. Holtslag, H. R. Hoogendoorn, J. M. Joosse, P. Parkkinen, M. Roukema, G. Sosef, N. Twigt, B. A. van Veen, R. N. van der Veen, A. H. Vermeulen, J. Winkelhagen, J. van der Zwaard, B. C. van Dieren, S. Goslings, J. C. Schepers, T. |
author_facet | Dingemans, S. A. Birnie, M. F. N. Sanders, F. R. K. van den Bekerom, M. P. J. Backes, M. van Beeck, E. Bloemers, F. W. van Dijkman, B. Flikweert, E. Haverkamp, D. Holtslag, H. R. Hoogendoorn, J. M. Joosse, P. Parkkinen, M. Roukema, G. Sosef, N. Twigt, B. A. van Veen, R. N. van der Veen, A. H. Vermeulen, J. Winkelhagen, J. van der Zwaard, B. C. van Dieren, S. Goslings, J. C. Schepers, T. |
author_sort | Dingemans, S. A. |
collection | PubMed |
description | BACKGROUND: Syndesmotic injuries are common and their incidence is rising. In case of surgical fixation of the syndesmosis a metal syndesmotic screw is used most often. It is however unclear whether this screw needs to be removed routinely after the syndesmosis has healed. Traditionally the screw is removed after six to 12 weeks as it is thought to hamper ankle functional and to be a source of pain. Some studies however suggest this is only the case in a minority of patients. We therefore aim to investigate the effect of retaining the syndesmotic screw on functional outcome. DESIGN: This is a pragmatic international multicentre randomised controlled trial in patients with an acute syndesmotic injury for which a metallic syndesmotic screw was placed. Patients will be randomised to either routine removal of the syndesmotic screw or removal on demand. Primary outcome is functional recovery at 12 months measured with the Olerud-Molander Score. Secondary outcomes are quality of life, pain and costs. In total 194 patients will be needed to demonstrate non-inferiority between the two interventions at 80% power and a significance level of 0.025 including 15% loss to follow-up. DISCUSSION: If removal on demand of the syndesmotic screw is non-inferior to routine removal in terms of functional outcome, this will offer a strong argument to adopt this as standard practice of care. This means that patients will not have to undergo a secondary procedure, leading to less complications and subsequent lower costs. TRIAL REGISTRATION: This study was registered at the Netherlands Trial Register (NTR5965), Clinicaltrials.gov (NCT02896998) on July 15th 2016. |
format | Online Article Text |
id | pubmed-5793393 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-57933932018-02-12 Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial) Dingemans, S. A. Birnie, M. F. N. Sanders, F. R. K. van den Bekerom, M. P. J. Backes, M. van Beeck, E. Bloemers, F. W. van Dijkman, B. Flikweert, E. Haverkamp, D. Holtslag, H. R. Hoogendoorn, J. M. Joosse, P. Parkkinen, M. Roukema, G. Sosef, N. Twigt, B. A. van Veen, R. N. van der Veen, A. H. Vermeulen, J. Winkelhagen, J. van der Zwaard, B. C. van Dieren, S. Goslings, J. C. Schepers, T. BMC Musculoskelet Disord Study Protocol BACKGROUND: Syndesmotic injuries are common and their incidence is rising. In case of surgical fixation of the syndesmosis a metal syndesmotic screw is used most often. It is however unclear whether this screw needs to be removed routinely after the syndesmosis has healed. Traditionally the screw is removed after six to 12 weeks as it is thought to hamper ankle functional and to be a source of pain. Some studies however suggest this is only the case in a minority of patients. We therefore aim to investigate the effect of retaining the syndesmotic screw on functional outcome. DESIGN: This is a pragmatic international multicentre randomised controlled trial in patients with an acute syndesmotic injury for which a metallic syndesmotic screw was placed. Patients will be randomised to either routine removal of the syndesmotic screw or removal on demand. Primary outcome is functional recovery at 12 months measured with the Olerud-Molander Score. Secondary outcomes are quality of life, pain and costs. In total 194 patients will be needed to demonstrate non-inferiority between the two interventions at 80% power and a significance level of 0.025 including 15% loss to follow-up. DISCUSSION: If removal on demand of the syndesmotic screw is non-inferior to routine removal in terms of functional outcome, this will offer a strong argument to adopt this as standard practice of care. This means that patients will not have to undergo a secondary procedure, leading to less complications and subsequent lower costs. TRIAL REGISTRATION: This study was registered at the Netherlands Trial Register (NTR5965), Clinicaltrials.gov (NCT02896998) on July 15th 2016. BioMed Central 2018-01-31 /pmc/articles/PMC5793393/ /pubmed/29386053 http://dx.doi.org/10.1186/s12891-018-1946-5 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Dingemans, S. A. Birnie, M. F. N. Sanders, F. R. K. van den Bekerom, M. P. J. Backes, M. van Beeck, E. Bloemers, F. W. van Dijkman, B. Flikweert, E. Haverkamp, D. Holtslag, H. R. Hoogendoorn, J. M. Joosse, P. Parkkinen, M. Roukema, G. Sosef, N. Twigt, B. A. van Veen, R. N. van der Veen, A. H. Vermeulen, J. Winkelhagen, J. van der Zwaard, B. C. van Dieren, S. Goslings, J. C. Schepers, T. Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial) |
title | Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial) |
title_full | Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial) |
title_fullStr | Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial) |
title_full_unstemmed | Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial) |
title_short | Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial) |
title_sort | routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (rodeo-trial) |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5793393/ https://www.ncbi.nlm.nih.gov/pubmed/29386053 http://dx.doi.org/10.1186/s12891-018-1946-5 |
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