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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

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 Thumbnail


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 3 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.

Citation

Watt, F., Corp, N., Kingsbury, S., Frobell, R., Englund, M., Felson, D., …Bierma-Zeinstra, S. (2019). 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. Osteoarthritis and Cartilage, 27(1), 23-33. https://doi.org/10.1016/j.joca.2018.08.001

Journal Article Type Article
Acceptance Date Aug 6, 2018
Online Publication Date Aug 18, 2018
Publication Date 2019-01
Publicly Available Date May 26, 2023
Journal Osteoarthritis and Cartilage
Print ISSN 1063-4584
Publisher Elsevier
Volume 27
Issue 1
Pages 23-33
DOI https://doi.org/10.1016/j.joca.2018.08.001
Keywords osteoarthritis, injury, outcome, clinical trial, knee, considerations
Publisher URL http://doi.org/10.1016/j.joca.2018.08.001

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