PEEK-OPTIMA as a Platform for Natural Total Knee Replacement
Lead Research Organisation:
University of Leeds
Department Name: Mechanical Engineering
Abstract
According to the National Joint Registry, Total Knee Replacement (TKR) is generally a successful elective operation, with more than 100,000 primary TKR procedures performed every year in England and Wales alone. However 5-10% require reoperation and replacement within 10 years of initial surgery, with the cost of some procedures reaching £75,000 per patient. Additionally, up to 30% of recipients report little or no symptom improvement and/or dissatisfaction with the results. The increasing cost of current product materials and globally decreasing market prices, together with an ageing population, changing patient expectations and increasing population BMI, creates the opportunity. A PEEK knee product can be manufactured with a 6 minute, one shot moulding process at a significant cost reduction over incumbent materials that can take 6 weeks to manufacture, offering opportunities for supply chain improvements. A first iteration of a PEEK femoral knee component has been developed and has been implanted into a small number of patients in a pre-market, global feasibility study designed to assess safety and efficacy. This device comprises a cemented femoral component used in conjunction with an all polyethylene tibia and patellar replacement. To optimise clinical outcomes for different groups of patients, additional variants of this TKR will be required, such as modular tibial components and cementless fixation options. This research programme is set to revolutionise knee replacement, using advanced materials technology combined with enhanced preclinical evaluation simulation methods to develop an affordable all polymer knee replacement that fixes securely into bone and minimises wear. The research will create a platform from which further medical treatment options could be developed, to meet other currently unmet needs (for example, long term soft tissue repair, facial reconstruction, metal sensitive orthopaedic patients).