Determining key clinical predictors for chronic ankle instability and return to sports with cost of illness analysis: protocol of a prospective cohort study

Jente Wagemans, Jan Taeymans, Kevin Kuppens, Heiner Baur, C M Bleakley, Dirk Vissers

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Abstract

Introduction: Ankle sprains are common in sports and the general population. Although considered innocuous, a large proportion has residual complaints such as recurrent ankle sprains and develop chronic ankle instability. Although some predicting factors are identified, there is no unequivocality regarding the development of chronic ankle instability, nor about the optimal rehabilitation for an acute ankle sprain. Alongside the biomechanical impairments, ankle sprains are a burden on society due to substantial economic costs. Therefore, we aim to identify key clinical predictors of chronic ankle instability or recovery after acute lateral ankle sprain. Additionally, we aim to determine cost-of-illness of patients who developed chronic ankle instability. Methods and analysis: This prospective cohort study (Clinicaltrials.gov: NCT05637008 - pre-results) aims to recruit adult (18–55 years) patients with an acute lateral ankle sprain who are active in sports. Clinical assessments and patient-reported outcome measures will be used to collect data at 7–14 days, 6 weeks, 12 weeks and 12 months after enrolment in the study. The primary outcome will be chronic ankle instability at 12-month follow-up. Salient outcomes will be analysed by logistic regression to determine association with the development of chronic ankle instability. Participants will fill in a cost diary containing direct and indirect costs related to their injury. Ethics and disseminations: The ethical committee of the Antwerp University Hospital (B3002022000138) has given approval of the protocol and consent forms on 10 October 2022. We perform this study according to the Helsinki Declaration. We will present results at conferences or webinars and publish in peer-reviewed articles. NCT05637008.
Original languageEnglish
Article numbere069867
Pages (from-to)1-11
Number of pages11
JournalBMJ Open
Volume13
Issue number5
Early online date10 May 2023
DOIs
Publication statusPublished (in print/issue) - 10 May 2023

Bibliographical note

The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
We gratefully acknowledge the contribution of Melanie Vandenberghe, MD, orthopaedic surgeon from the AZ Monica Hospital, Antwerp, Belgium. Her contribution during recruitment for the feasibility study was vital for the final shape of the study protocol.

© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Publisher Copyright:
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Publisher Copyright:
© 2023 BMJ Publishing Group. All rights reserved.

Keywords

  • foot & ankle
  • health economics
  • musculoskeletal disorders
  • rehabilitation medicine

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