Understanding barriers to clinical adoption of total ankle replacement in the treatment of ankle osteoarthritis to develop future interventions

Osteoarthritis of the ankle affects approximately 1-3% of the global population, and is reported in more than 1.5 million patients in the UK. Typically, patients with ankle osteoarthritis are younger than those that develop hip or knee arthritis. Ankle osteoarthritis has a huge impact on quality of life and patient mobility. For osteoarthritis in general, total joint replacement surgery is often used to treat late stage arthritis. However, less than one thousand patients receive an ankle replacement annually in the UK, and ankle replacement is far less successful than hip or knee replacement. There is a huge unmet need for a well functioning device that is simple to implant for this patient group.

A purely engineering approach to implant design has been shown to have limitations in other joint replacements. Engagement with all stakeholders to determine the key requirements of a new device will provide an excellent platform for research to optimise existing solutions and approaches, or to develop an entirely new device. The applicant has a medical engineering background and extensive experience in engineering simulation of joint replacement performance and has been developing a research group focused on bioengineering in the ankle. She is aiming to improve the performance of total ankle replacement, to provide a real solution to a wider range of ankle arthritis patients.

This discipline hopping grant would embed the applicant within a clinical environment to engage with the stakeholders through the following activities:

i) Observation of out-patient clinics and the treatment-decision pathway for ankle arthritis patients (Chapel Allerton Hospital, Leeds)
ii) Observation of ankle surgery - total ankle replacement and fusion, to identify the key challenges within the surgical technique at three leading ankle replacement centres within the UK.
iii) Hands-on experience of total ankle replacement through a cadaver training course
iv) Undertaking a national survey of ankle surgeons, to extend the information received from a wide range of surgeons, with different levels of experience
v) Patient engagement through a focused interview group (based at Chapel Allerton Hospital, Leeds), and a broader national survey

To support these activities, the applicant has proposed a training programme during the grant including Good Clinical Practice, Patient Engagement Training, a Healthcare Economics summer school and will attend seminars with the surgical trainees at Chapel Allerton Hospital.

Ultimately, this grant will allow her to increase her knowledge of the surgeon and patient needs for total ankle replacement enabling her to define a robust specification for future ankle replacement design that successfully meets the needs of a wider range of patients. The relationships with surgeons and patients developed through the discipline hop will continue in collaborative research development in the future.

Ankle arthritis affects more than 1% of the global population (in excess of 70 million adults) and has a significant impact on the quality of life for many patients. Currently, total ankle replacement does not provide a robust clinical solution for these patients. Although there will be little direct research output due to this being a discipline hopping grant to develop knowledge and skills, the project will make a significant contribution to the future improvement and development of ankle replacement interventions. To date there appears to have been limited engagement between clinicians, engineers and patients for providing a solution for ankle arthritis. This project will develop a stratified classification for clinical need and user requirements, alongside a comprehensive definition of the ankle OA patient population, leading to a range of robust design requirements for treatment of ankle OA and TAR being identified. The knowledge generated through this discipline hopping grant will enable future translation through research projects to create engineering solutions that are differentiated to meet the range of needs identified.
Beyond the scope of this grant, the project will benefit surgeons, patients, the NHS and the engineering base involved in ankle replacement design. The knowledge generated within this discipline hop will form the foundation of research projects focused on developing successful, cost-effective interventions for the treatment of ankle osteoarthritis, based on the specification developed from the information gathered through this grant. The two main surgical interventions for ankle osteoarthritis - fusion or TAR - both have limitations and are not suitable for the whole ankle OA population. Through this project, and by consulting with both surgeons and patients to define the user requirements, a platform for undertaking research to develop a successful treatment option will be created. The long-term aim is to use this information to create a suite of better treatment options available to the surgeon to use within specifically targeted patients.