Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: 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.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
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
_version_ 1783296942302822400
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
work_keys_str_mv AT dingemanssa routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT birniemfn routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT sandersfrk routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT vandenbekerommpj routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT backesm routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT vanbeecke routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT bloemersfw routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT vandijkmanb routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT flikweerte routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT haverkampd routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT holtslaghr routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT hoogendoornjm routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT joossep routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT parkkinenm routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT roukemag routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT sosefn routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT twigtba routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT vanveenrn routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT vanderveenah routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT vermeulenj routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT winkelhagenj routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT vanderzwaardbc routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT vandierens routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT goslingsjc routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial
AT scheperst routineversusondemandremovalofthesyndesmoticscrewaprotocolforaninternationalrandomisedcontrolledtrialrodeotrial