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 language | English |
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Article number | 100449 |
Number of pages | 11 |
Journal | Osteoarthritis and Cartilage Open |
Volume | 6 |
Issue number | 2 |
Early online date | 23 Feb 2024 |
DOIs | |
Publication status | Published - 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.
Funders | Funder number |
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Centre for Sport, Exercise and Osteoarthritis Research Versus Arthritis | |
UK Research and Innovation | |
Arthritis Society | STAR 19–0493 |
Michael Smith Health Research BC | SCH-2020-0403 |
Medical Research Council | MR/Y003470/1, MR/S016538/1, MR/S016538/2 |
National Institute for Health and Care Research | |
National Health and Medical Research Council | GNT2008523 |
Versus Arthritis | 21595 |
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