Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial)

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, 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

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.

Keywords: Functional outcome; Removal on demand; Routine removal; Syndesmosis; Syndesmotic screw.

Conflict of interest statement

Ethics approval and consent to participate

The study has received ethical approval from the Medical Ethical Review Committee (METC) of the Academic Medical Centre and the Operational Ethics Committee of the Hospital District of Helsinki and Uusimaa. All participating subjects have signed an informed consent form before entering the study.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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