1. 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
- Author
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Watt, FE, Corp, N, Kingsbury, SR, Frobell, R, Englund, M, Felson, DT, Levesque, M, Majumdar, S, Wilson, C, Beard, DJ, Lohmander, LS, Kraus, VB, Roemer, F, Conaghan, PG, Mason, DJ, Group, Arthritis Research UK Osteoarthritis and Crystal Disease Clinical Study Group Expert Working, Adams, J, Blank, M, Batt, M, Biggs, P, Busse-Morris, M, Button, K, Calder, J, Cook, J, Edwards, C, Fisheleva, E, Hamilton, DF, 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
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Health Sciences ,Osteoarthritis ,Aging ,Arthritis ,Prevention ,Clinical Trials and Supportive Activities ,Clinical Research ,Physical Injury - Accidents and Adverse Effects ,Musculoskeletal ,Good Health and Well Being ,Acute Disease ,Clinical Trials as Topic ,Evidence-Based Medicine ,Humans ,Knee Injuries ,Osteoarthritis ,Knee ,Research Design ,Treatment Outcome ,Injury ,Outcome ,Clinical trial ,Knee ,Considerations ,Arthritis Research UK Osteoarthritis and Crystal Disease Clinical Study Group Expert Working Group ,Biomedical Engineering ,Human Movement and Sports Sciences ,Arthritis & Rheumatology ,Clinical sciences ,Sports science and exercise - Abstract
ObjectiveThere 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.DesignAn 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.ResultsThe 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.ConclusionsThese considerations represent the first international consensus on the conduct of interventional studies following acute knee joint trauma.
- Published
- 2019