F.E. Watt
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
Watt, F.E.; Corp, N.; Kingsbury, S.R.; Frobell, R.; Englund, M.; Felson, D.T.; Levesque, M.; Majumdar, S.; Wilson, C.; Beard, D.J.; Lohmander, L.S.; Kraus, V.B.; Roemer, F.; Conaghan, P.G.; Mason, D.J.; Adams, J.; Blank, M.; Batt, M.; Biggs, P.; Busse-Morris, M.; Button, K.; Calder, J.; Cook, J.; Edwards, C.; Fisheleva, E.; Hamilton, D.F.; Harrison, H.; Holt, C.; Jones, M.; Jones, R.; Kluzek, S.; Knight, T.; Nuki, G.; Parekh, S.; Peat, G.; Pothet, C.; Rainer, T.; Robinson, N.; Sawle, L.; Vincent, T.; Williams, A.; Wise, E.; Zhang, W.; Bierma-Zeinstra, S.
Authors
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
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
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.
Citation
Watt, F., Corp, N., Kingsbury, S., Frobell, R., Englund, M., Felson, D., Levesque, M., Majumdar, S., Wilson, C., Beard, D., Lohmander, L., Kraus, V., Roemer, F., Conaghan, P., Mason, D., Adams, J., Blank, M., Batt, M., Biggs, P., Busse-Morris, M., …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 17, 2018 |
Publication Date | 2019-01 |
Deposit Date | Nov 9, 2020 |
Publicly Available Date | Nov 11, 2020 |
Journal | Osteoarthritis and Cartilage |
Print ISSN | 1063-4584 |
Publisher | Elsevier |
Peer Reviewed | Peer Reviewed |
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 |
Public URL | http://researchrepository.napier.ac.uk/Output/2698407 |
Files
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
(390 Kb)
PDF
Publisher Licence URL
http://creativecommons.org/licenses/by/4.0/
Copyright Statement
Published under a Creative Commons Attribution (CC BY 4.0) license.
Downloadable Citations
About Edinburgh Napier Research Repository
Administrator e-mail: repository@napier.ac.uk
This application uses the following open-source libraries:
SheetJS Community Edition
Apache License Version 2.0 (http://www.apache.org/licenses/)
PDF.js
Apache License Version 2.0 (http://www.apache.org/licenses/)
Font Awesome
SIL OFL 1.1 (http://scripts.sil.org/OFL)
MIT License (http://opensource.org/licenses/mit-license.html)
CC BY 3.0 ( http://creativecommons.org/licenses/by/3.0/)
Powered by Worktribe © 2024
Advanced Search