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

Research output: Contribution to journalArticle

Abstract

Objective: There are few guidelines for clinical trials of interventions for prevention of post-traumatic osteoarthritis (PTOA), reflecting challenges in this area. An international multi-disciplinary expert group including patients was convened to generate points to consider for the design and conduct of interventional studies following acute knee injury. Design: An evidence review on acute knee injury interventional studies to prevent PTOA was presented to the group, alongside overviews of challenges in this area, including potential targets, biomarkers and imaging. Working groups considered pre-identified key areas: eligibility criteria and outcomes, biomarkers, injury definition and intervention timing including multi-modality interventions. Consensus agreement within the group on points to consider was generated and is reported here after iterative review by all contributors. Results: The evidence review identified 37 studies. Study duration and outcomes varied widely and 70% examined surgical interventions. Considerations were grouped into three areas: justification of inclusion criteria including the classification of injury and participant age (as people over 35 may have pre-existing OA); careful consideration in the selection and timing of outcomes or biomarkers; definition of the intervention(s)/comparator(s) and the appropriate time-window for intervention (considerations may be particular to intervention type). Areas for further research included demonstrating the utility of patient-reported outcomes, biomarkers and imaging outcomes from ancillary/cohort studies in this area, and development of surrogate clinical trial endpoints that shorten the duration of clinical trials and are acceptable to regulatory agencies. Conclusions: These considerations represent the first international consensus on the conduct of interventional studies following acute knee joint trauma.

Details

Authors
  • F. E. Watt
  • N. Corp
  • S. R. Kingsbury
  • D. T. Felson
  • M. Levesque
  • S. Majumdar
  • C. Wilson
  • D. J. Beard
  • V. B. Kraus
  • P. G. Conaghan
  • D. J. Mason
  • J. Adams
  • M. Blank
  • M. Batt
  • P. Biggs
  • M. Busse-Morris
  • K. Button
  • J. Calder
  • J. Cook
  • C. Edwards
  • E. Fisheleva
  • D. F. Hamilton
  • H. Harrison
  • C. Holt
  • M. Jones
  • R. Jones
  • S. Kluzek
  • T. Knight
  • G. Nuki
  • S. Parekh
  • G. Peat
  • C. Pothet
  • T. Rainer
  • N. Robinson
  • L. Sawle
  • T. Vincent
  • A. Williams
  • E. Wise
  • W. Zhang
  • S. Bierma-Zeinstra
Organisations
External organisations
  • Keele University
  • University of Leeds
  • Boston University
  • University of Manchester
  • AbbVie
  • University of Texas Health Science Centre
  • University of Oxford
  • Duke University
  • Friedrich-Alexander University Erlangen-Nürnberg
  • Cardiff University
  • University of Southampton
  • University of Nottingham
  • University of Edinburgh
  • University of Salford
  • University College London
  • London South Bank University
  • Erasmus University Medical Center
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Health Care Service and Management, Health Policy and Services and Health Economy
  • Rheumatology and Autoimmunity

Keywords

  • Clinical trial, Considerations, Injury, Knee, Osteoarthritis, Outcome
Original languageEnglish
Pages (from-to)23-33
JournalOsteoarthritis and Cartilage
Volume27
Issue number1
Early online date2018
Publication statusPublished - 2019 Jan
Publication categoryResearch
Peer-reviewedYes