Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial)
Abstract 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...
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doaj-144166efca8a4dbcbcab91fe6f8097482020-11-24T22:21:42ZengBMCBMC Musculoskeletal Disorders1471-24742018-01-011911610.1186/s12891-018-1946-5Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial)S. A. Dingemans0M. F. N. Birnie1F. R. K. Sanders2M. P. J. van den Bekerom3M. Backes4E. van Beeck5F. W. Bloemers6B. van Dijkman7E. Flikweert8D. Haverkamp9H. R. Holtslag10J. M. Hoogendoorn11P. Joosse12M. Parkkinen13G. Roukema14N. Sosef15B. A. Twigt16R. N. van Veen17A. H. van der Veen18J. Vermeulen19J. Winkelhagen20B. C. van der Zwaard21S. van Dieren22J. C. Goslings23T. Schepers24Department of Surgery, Trauma Unit, Academic Medical Centre, University of AmsterdamDepartment of Surgery, Trauma Unit, Academic Medical Centre, University of AmsterdamDepartment of Surgery, Trauma Unit, Academic Medical Centre, University of AmsterdamDepartment of Orthopedic Surgery, OLVGDepartment of Surgery, Trauma Unit, Academic Medical Centre, University of AmsterdamDepartment of Public Health, Erasmus MCDepartment of Surgery, Trauma Unit, VU University Medical CentreDepartment of Surgery, Flevo HospitalDepartment of Surgery, Deventer HospitalDepartment of Surgery, Slotervaart HospitalDepartment of Surgery, Trauma Unit, Academic Medical Centre, University of AmsterdamDepartment of Surgery, Haaglanden MCDepartment of Surgery, Noordwest Hospital GroupDepartment of Orthopaedics and Traumatology, Helsinki University HospitalDepartment of Surgery, Maasstad HospitalDepartment of Surgery, Spaarne HospitalDepartment of Surgery, BovenIJ HospitalDepartment of Surgery, OLVGDepartment of Surgery, Catharina HospitalDepartment of Surgery, Spaarne HospitalDepartment of Surgery, Westfries HospitalDepartment of Orthopaedics, Jeroen Bosch HospitalDepartment of Surgery, Trauma Unit, Academic Medical Centre, University of AmsterdamDepartment of Orthopedic Surgery, OLVGDepartment of Surgery, Trauma Unit, Academic Medical Centre, University of AmsterdamAbstract 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.http://link.springer.com/article/10.1186/s12891-018-1946-5SyndesmosisSyndesmotic screwRoutine removalRemoval on demandFunctional outcome |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
S. A. Dingemans M. F. N. Birnie F. R. K. Sanders M. P. J. van den Bekerom M. Backes E. van Beeck F. W. Bloemers B. van Dijkman E. Flikweert D. Haverkamp H. R. Holtslag J. M. Hoogendoorn P. Joosse M. Parkkinen G. Roukema N. Sosef B. A. Twigt R. N. van Veen A. H. van der Veen J. Vermeulen J. Winkelhagen B. C. van der Zwaard S. van Dieren J. C. Goslings T. Schepers |
spellingShingle |
S. A. Dingemans M. F. N. Birnie F. R. K. Sanders M. P. J. van den Bekerom M. Backes E. van Beeck F. W. Bloemers B. van Dijkman E. Flikweert D. Haverkamp H. R. Holtslag J. M. Hoogendoorn P. Joosse M. Parkkinen G. Roukema N. Sosef B. A. Twigt R. N. van Veen A. H. van der Veen J. Vermeulen J. Winkelhagen B. C. van der Zwaard S. van Dieren J. C. Goslings T. Schepers Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial) BMC Musculoskeletal Disorders Syndesmosis Syndesmotic screw Routine removal Removal on demand Functional outcome |
author_facet |
S. A. Dingemans M. F. N. Birnie F. R. K. Sanders M. P. J. van den Bekerom M. Backes E. van Beeck F. W. Bloemers B. van Dijkman E. Flikweert D. Haverkamp H. R. Holtslag J. M. Hoogendoorn P. Joosse M. Parkkinen G. Roukema N. Sosef B. A. Twigt R. N. van Veen A. H. van der Veen J. Vermeulen J. Winkelhagen B. C. van der Zwaard S. van Dieren J. C. Goslings T. Schepers |
author_sort |
S. A. Dingemans |
title |
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_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_sort |
routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (rodeo-trial) |
publisher |
BMC |
series |
BMC Musculoskeletal Disorders |
issn |
1471-2474 |
publishDate |
2018-01-01 |
description |
Abstract 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. |
topic |
Syndesmosis Syndesmotic screw Routine removal Removal on demand Functional outcome |
url |
http://link.springer.com/article/10.1186/s12891-018-1946-5 |
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