Enhanced stratified pre-clinical simulation of the natural knee

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The clinical need for this project is in the ability to develop and translate safe and reliable medical device technology in the tibio-femoral joint for treatment of degenerative joint disease. Current options for young and active patients with degenerative joint disease - such as mosaicplasty or MACI - are limited, with very limited success, and can be costly. Further, such interventions have not been pre-clinically tested. Surgeons are reluctant to carry out total joint replacement in younger patients, leaving them in pain and for the condition to worsen before any intervention takes place. There is a clinical need both for improved interventions, and for stratified pre-clinical simulation methods to assess the intervention before it is offered to the patient. Such pre-clinical simulation methods will ultimately be adopted by companies developing tissue repair interventions to support their product development process and to reduce risk of costly failures both to them and patients.The research challenge is to develop experimental simulation methods that can be used to pre-clinically assess and predict biomechanical and tribological function of tissue repair interventions in the natural tibio-femoral joint.The specific research questions are as follows:1. Can knee experimental simulation models be developed that mimic knee conditions from patients with different knee diseases and pathology (e.g. cartilage defect, ligament defect, meniscus defect, bone defect)?2. Can enhanced pre-clinical experimental simulation methods be developed that can evaluate different knee therapies and interventions? And differentiate between different interventions (of the same type)?Addressing these questions will guide the stratification and development of enhanced experimental simulation methods for biomechanical/tribological function. Currently scaffolds or other tissue repair interventions move directly into animal studies without functional tribological or biomechanical studies, which can lead to costly failures in animals as well as in the clinic. Projects to commercially develop and get CE mark for early repair interventions such as scaffolds cost of the order of £1 to 3m, followed by similar investments to support clinical trials and post market activity. Pre-clinical simulation will support this activity and reduce the risk of unsuccessful outcomes in clinical studies.