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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
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

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.

Clinical trial, Considerations, Injury, Knee, Osteoarthritis, Outcome
1063-4584
23-33
Watt, F.E.
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Corp, N.
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Roemer, F.
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Conaghan, P.G.
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Batt, M.
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Biggs, P.
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Button, K.
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Calder, J.
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Cook, J.
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Edwards, C.
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Fisheleva, E.
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Hamilton, D. F.
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Harrison, H.
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Holt, C.
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Jones, M.
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Jones, R.
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Kluzek, S.
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Knight, T.
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Nuki, G.
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Parekh, S.
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Peat, G.
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Pothet, C.
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Rainer, T.
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Robinson, N.
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Sawle, L.
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Vincent, T.
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Williams, A.
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Wise, E.
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Zhang, W.
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Bierma-Zeinstra, S.
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Watt, F.E.
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Corp, N.
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Kingsbury, S.R.
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Frobell, R.
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Englund, M.
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Felson, D.T.
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Levesque, M.
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Majumdar, S.
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Wilson, C.
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Beard, D.J.
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Lohmander, L.S.
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Kraus, V.B.
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Roemer, F.
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Conaghan, P.G.
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Mason, D.J.
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Adams, J.
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Batt, M.
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Biggs, P.
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Busse-Morris, M.
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Button, K.
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Calder, J.
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Cook, J.
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Edwards, C.
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Fisheleva, E.
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Hamilton, D. F.
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Harrison, H.
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Holt, C.
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Jones, M.
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Jones, R.
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Kluzek, S.
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Knight, T.
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Nuki, G.
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Parekh, S.
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Peat, G.
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Pothet, C.
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Rainer, T.
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Robinson, N.
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Sawle, L.
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Vincent, T.
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Williams, A.
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Wise, E.
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Zhang, W.
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Bierma-Zeinstra, S.
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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. and 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. (doi:10.1016/j.joca.2018.08.001).

Record type: Article

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.

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Accepted/In Press date: 6 August 2018
e-pub ahead of print date: 18 August 2018
Published date: January 2019
Keywords: Clinical trial, Considerations, Injury, Knee, Osteoarthritis, Outcome

Identifiers

Local EPrints ID: 423622
URI: http://eprints.soton.ac.uk/id/eprint/423622
ISSN: 1063-4584
PURE UUID: ec723e39-8bcf-4b13-a4f3-936562a4c4d4
ORCID for J. Adams: ORCID iD orcid.org/0000-0003-1765-7060

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Date deposited: 27 Sep 2018 16:30
Last modified: 18 Feb 2021 16:44

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Contributors

Author: F.E. Watt
Author: N. Corp
Author: S.R. Kingsbury
Author: R. Frobell
Author: M. Englund
Author: D.T. Felson
Author: M. Levesque
Author: S. Majumdar
Author: C. Wilson
Author: D.J. Beard
Author: L.S. Lohmander
Author: V.B. Kraus
Author: F. Roemer
Author: P.G. Conaghan
Author: D.J. Mason
Author: J. Adams ORCID iD
Author: M. Blank
Author: M. Batt
Author: P. Biggs
Author: M. Busse-Morris
Author: K. Button
Author: J. Calder
Author: J. Cook
Author: C. Edwards
Author: E. Fisheleva
Author: D. F. Hamilton
Author: H. Harrison
Author: C. Holt
Author: M. Jones
Author: R. Jones
Author: S. Kluzek
Author: T. Knight
Author: G. Nuki
Author: S. Parekh
Author: G. Peat
Author: C. Pothet
Author: T. Rainer
Author: N. Robinson
Author: L. Sawle
Author: T. Vincent
Author: A. Williams
Author: E. Wise
Author: W. Zhang
Author: S. Bierma-Zeinstra

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