Toward designing human intervention studies to prevent osteoarthritis after knee injury: A report from an interdisciplinary OARSI 2023 workshop

Jackie L Whittaker, Raneem Kalsoum, James Bilzon, Philip G Conaghan, Kay Crossley, George R Dodge, Alan Getgood, Xiaojuan Li, Elena Losina, Deborah J Mason, Brian Pietrosimone, May Arna Risberg, Frank Roemer, David Felson, Adam G Culvenor, Duncan Meuffels, Nicole Gerwin, Lee S Simon, L Stefan Lohmander, Martin EnglundFiona E Watt

Research output: Contribution to journalArticlepeer-review

1 Citation (SciVal)

Abstract

OBJECTIVE: The global impact of osteoarthritis is growing. Currently no disease modifying osteoarthritis drugs/therapies exist, increasing the need for preventative strategies. Knee injuries have a high prevalence, distinct onset, and strong independent association with post-traumatic osteoarthritis (PTOA). Numerous groups are embarking upon research that will culminate in clinical trials to assess the effect of interventions to prevent knee PTOA despite challenges and lack of consensus about trial design in this population. Our objectives were to improve awareness of knee PTOA prevention trial design and discuss state-of-the art methods to address the unique opportunities and challenges of these studies.

DESIGN: An international interdisciplinary group developed a workshop, hosted at the 2023 Osteoarthritis Research Society International Congress. Here we summarize the workshop content and outputs, with the goal of moving the field of PTOA prevention trial design forward.

RESULTS: Workshop highlights included discussions about target population (considering risk, homogeneity, and possibility of modifying osteoarthritis outcome); target treatment (considering delivery, timing, feasibility and effectiveness); comparators (usual care, placebo), and primary symptomatic outcomes considering surrogates and the importance of knee function and symptoms other than pain to this population.

CONCLUSIONS: Opportunities to test multimodal PTOA prevention interventions across preclinical models and clinical trials exist. As improving symptomatic outcomes aligns with patient and regulator priorities, co-primary symptomatic (single or aggregate/multidimensional outcome considering function and symptoms beyond pain) and structural/physiological outcomes may be appropriate for these trials. To ensure PTOA prevention trials are relevant and acceptable to all stakeholders, future research should address critical knowledge gaps and challenges.

Original languageEnglish
Article number100449
Number of pages11
JournalOsteoarthritis and Cartilage Open
Volume6
Issue number2
Early online date23 Feb 2024
DOIs
Publication statusPublished - 1 Jun 2024

Funding

FW is a recipient of a fellowship from UK Research & Innovation, a UK government supported research which includes the Medical Research Council (MR/S016538/1, MR/S016538/2 and MR/Y003470/1). This fellowship directly supported FW and RK in their time in coordinating all aspects of this work and in the writing of the manuscript. JW is supported by an Arthritis Society (Canada) STARS career development award (STAR 19–0493) and Michael Smith Health Research BC Scholar award (SCH-2020-0403). AC is a recipient of a National Health and Medical Research Council (NHMRC) of Australia Investigator Grant (GNT2008523). PC is supported in part by the United Kingdom National Institute for Health and Care Research (NIHR) Leeds Biomedical Research Centre. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health. The Centre for Sport, Exercise and Osteoarthritis Research Versus Arthritis (funded by Versus Arthritis, 21595) covered limited speaker travel costs associated with the workshop.

FundersFunder number
Centre for Sport, Exercise and Osteoarthritis Research Versus Arthritis
UK Research and Innovation
Arthritis SocietySTAR 19–0493
Michael Smith Health Research BCSCH-2020-0403
Medical Research CouncilMR/Y003470/1, MR/S016538/1, MR/S016538/2
National Institute for Health and Care Research
National Health and Medical Research CouncilGNT2008523
Versus Arthritis21595
Leeds Biomedical Research Centre

Keywords

  • Knee
  • Osteoarthritis
  • Post-traumatic osteoarthritis
  • Prevention
  • Randomised controlled trials
  • Trial design

ASJC Scopus subject areas

  • Rehabilitation
  • Biomedical Engineering
  • Orthopedics and Sports Medicine

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