Towards prevention of post-traumatic osteoarthritis: report from an international expert working group on considerations for the design and conduct of interventional studies following acute knee injury

F. E. Watt*, N. Corp, S. R. Kingsbury, R. Frobell, M. Englund, D. T. Felson, M. Levesque, S. Majumdar, C. Wilson, D. J. Beard, L. S. Lohmander, V. B. Kraus, F. Roemer, P. G. Conaghan, D. J. Mason, Arthritis Research UK Osteoarthritis and Crystal Disease Clinical Study Group Expert Working Group

*Corresponding author for this work

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Abstract

Objective: There are few guidelines for clinical trials ofinterventions for prevention of post-traumatic osteoarthritis (PTOA),reflecting challenges in this area. An international multi-disciplinary expertgroup including patients was convened to generate points to consider for thedesign and conduct of interventional studies following acute knee injury.Design: An evidence review on acute knee injury interventional studies toprevent PTOA was presented to the group, alongside overviews of challenges inthis area, including potential targets, biomarkers and imaging. Working groupsconsidered pre-identified key areas: eligibility criteria and outcomes,biomarkers, injury definition and intervention timing including multi-modalityinterventions. Consensus agreement within the group on points to consider wasgenerated and is reported here after iterative review by all contributors.Results: The evidence review identified 37 studies. Study duration and outcomesvaried widely and 70% examined surgical interventions. Considerations weregrouped into three areas: justification of inclusion criteria including theclassification of injury and participant age (as people over 35 may havepre-existing OA); careful consideration in the selection and timing of outcomesor biomarkers; definition of the intervention(s)/comparator(s) and theappropriate time-window for intervention (considerations may be particular tointervention type). Areas for further research included demonstrating theutility of patient reported outcomes, biomarkers and imaging outcomes fromancillary/cohort studies in this area, and development of surrogate clinicaltrial endpoints that shorten the duration of clinical trials and are acceptableto regulatory agencies. Conclusions: These considerations represent the firstinternational consensus on the conduct of interventional studies followingacute knee joint trauma.

Original languageEnglish
Pages (from-to)23-33
Number of pages11
JournalOsteoarthritis and Cartilage
Volume27
Issue number1
Early online date17 Aug 2018
DOIs
Publication statusPublished - 1 Jan 2019

Keywords

  • Osteoarthritis
  • Injury
  • Outcome
  • Clinical trial
  • Knee
  • Considerations

ASJC Scopus subject areas

  • Rheumatology
  • Biomedical Engineering
  • Orthopedics and Sports Medicine

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