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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.

dc.contributor.author Kraus, Virginia
dc.contributor.author Watt, FE
dc.contributor.author Corp, N
dc.contributor.author Kingsbury, SR
dc.contributor.author Frobell, R
dc.contributor.author Englund, M
dc.contributor.author Felson, DT
dc.contributor.author Levesque, M
dc.contributor.author Majumdar, S
dc.contributor.author Wilson, C
dc.contributor.author Beard, DJ
dc.contributor.author Lohmander, LS
dc.contributor.author Roemer, F
dc.contributor.author Conaghan, PG
dc.contributor.author Mason, DJ
dc.date.accessioned 2019-02-02T15:26:33Z
dc.date.available 2019-02-02T15:26:33Z
dc.date.issued 2019-01
dc.identifier S1063-4584(18)31412-2
dc.identifier.issn 1063-4584
dc.identifier.issn 1522-9653
dc.identifier.uri https://hdl.handle.net/10161/18043
dc.description.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.
dc.language eng
dc.publisher Elsevier BV
dc.relation.ispartof Osteoarthritis and cartilage
dc.relation.isversionof 10.1016/j.joca.2018.08.001
dc.subject Arthritis Research UK Osteoarthritis and Crystal Disease Clinical Study Group Expert Working Group
dc.title 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.
dc.type Journal article
dc.date.updated 2019-02-02T15:26:32Z
pubs.begin-page 23
pubs.end-page 33
pubs.issue 1
pubs.organisational-group School of Medicine
pubs.organisational-group Duke
pubs.organisational-group Duke Molecular Physiology Institute
pubs.organisational-group Institutes and Centers
pubs.organisational-group Orthopaedics
pubs.organisational-group Clinical Science Departments
pubs.organisational-group Pathology
pubs.organisational-group Medicine, Rheumatology and Immunology
pubs.organisational-group Medicine
pubs.publication-status Published
pubs.volume 27


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