The working group, convened by researchers from the universities of Oxford, Leeds and Cardiff developed a set of considerations on the design and conduct of interventional studies which aim to prevent OA in patients who have had an acute knee injury. These considerations are intended to underpin future guidelines as the field evolves.
Joint injury is one of the biggest risk factors for OA, with 50% of people with significant knee injuries developing what is called post-traumatic OA (PTOA) within 10 years.
"Prevention of OA is as crucial as developing new therapies for established osteoarthritis", says research co-lead Dr Fiona Watt, at the Arthritis Research UK Centre for Osteoarthritis Pathogenesis, Kennedy Institute, University of Oxford. "We were able to bring together a team of experts from diverse areas, from fundamental science to clinical trialists and the pharmaceutical industry, to focus on improving our research approach to testing new treatments at the time of a joint injury, with a view of improving healthcare."
Currently, there are no specific guidelines for clinical trials measuring the effect of interventions for OA prevention after injury, with this type of study presenting a number of particular challenges. These include the window of opportunity for any given intervention and the potential duration of study needed for meaningful results meaning that earlier 'surrogate' outcomes will be important.
The initial considerations identified by the group include information on who should be included in such trials, timing of intervention, what outcomes should be collected and at what times, the importance of comparators including placebo treatments and the importance of linking with pre-clinical models of joint injury and human cohort studies to inform future design of studies. Critical knowledge gaps and areas for future research have been highlighted as part of this work.
"Exciting advances in preclinical studies indicate that intervention at the time of injury could reduce or delay PTOA" says co-lead Deborah Mason from Cardiff University. "This paper is important as it starts to provide a pathway towards testing such treatments in human clinical trials."
The team concluded that if we are to improve care and deliver new therapeutics which benefit patients, progress in the field of OA prevention is urgently required, in spite of its challenges.
The research was funded by Arthritis Research UK.