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(s)
Type
Journal 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.
Date Issued
2019-01-01
Date Acceptance
2018-08-06
Citation
Osteoarthritis and Cartilage, 2019, 27 (1), pp.23-33
ISSN
1063-4584
Publisher
Elsevier
Start Page
23
End Page
33
Journal / Book Title
Osteoarthritis and Cartilage
Volume
27
Issue
1
Copyright Statement
©2019 The Authors. Published by Elsevier Ltd on behalf of Osteoarthritis Research Society International. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)
License URL
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/30125638
PII: S1063-4584(18)31412-2
Subjects
Clinical trial
Considerations
Injury
Knee
Osteoarthritis
Outcome
Acute Disease
Clinical Trials as Topic
Evidence-Based Medicine
Humans
Knee Injuries
Osteoarthritis, Knee
Research Design
Treatment Outcome
Publication Status
Published
Coverage Spatial
England
Date Publish Online
2018-08-18