Objective: There are few guidelines for clinical trials ofinterventions for prevention of post-traumatic osteoarthritis (PTOA),reflecting challenges in this area. An international multi-disciplinary expertgroup including patients was convened to generate points to consider for thedesign and conduct of interventional studies following acute knee injury.Design: An evidence review on acute knee injury interventional studies toprevent PTOA was presented to the group, alongside overviews of challenges inthis area, including potential targets, biomarkers and imaging. Working groupsconsidered pre-identified key areas: eligibility criteria and outcomes,biomarkers, injury definition and intervention timing including multi-modalityinterventions. Consensus agreement within the group on points to consider wasgenerated and is reported here after iterative review by all contributors.Results: The evidence review identified 37 studies. Study duration and outcomesvaried widely and 70% examined surgical interventions. Considerations weregrouped into three areas: justification of inclusion criteria including theclassification of injury and participant age (as people over 35 may havepre-existing OA); careful consideration in the selection and timing of outcomesor biomarkers; definition of the intervention(s)/comparator(s) and theappropriate time-window for intervention (considerations may be particular tointervention type). Areas for further research included demonstrating theutility of patient reported outcomes, biomarkers and imaging outcomes fromancillary/cohort studies in this area, and development of surrogate clinicaltrial endpoints that shorten the duration of clinical trials and are acceptableto regulatory agencies. Conclusions: These considerations represent the firstinternational consensus on the conduct of interventional studies followingacute knee joint trauma.
- Clinical trial
ASJC Scopus subject areas
- Biomedical Engineering
- Orthopedics and Sports Medicine