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

BMJ Open. 2023 May 10;13(5):e069867. doi: 10.1136/bmjopen-2022-069867.


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 ( 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.

Keywords: foot & ankle; health economics; musculoskeletal disorders; rehabilitation medicine.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adult
  • Ankle
  • Ankle Injuries* / complications
  • Cost of Illness
  • Humans
  • Joint Instability* / complications
  • Prospective Studies
  • Return to Sport
  • Sprains and Strains*

Associated data