SOFARI Clinical Outcomes Registry

The aim of this protocol is to design and implement a clinical quality orthopaedic registry for patients presenting to Drs Michael Symes and Andrew Wines (orthopaedic surgeons) with foot and ankle pathologies. The purpose of the registry is to report patient outcomes after treatment through a retrospective and prospective, consecutive observational cohort study design. This clinical registry will collate and store patient demographic, treatment and clinical data as well as patient outcomes collected routinely as part of the standard clinical pathway for foot and ankle pathology treatments. Outcomes will include clinical outcomes, patient reported outcomes and rates of adverse events following treatment. Recruitment will include all patients presenting with foot and ankle pathology to the principal investigators (Drs Michael Symes and Andrew Wines) at their clinical practices. Patients will be presented with a Participant Information Sheet to inform them of the nature of the registry and will be given an opportunity to provide informed consent for collection of their clinical data for research purposes via an opt-out approach. Patients will undergo standard of care consultation for diagnosis and treatment, including the collection of demographic data, patient medical history, radiological findings and pathology. Data collection will be completed routinely at the consulting rooms for the principal investigators. Patients will in addition be requested to complete a set of questionnaires (EQ-5D-5L, Foot and Ankle Outcome Score, FAOS) to enable evaluation of patient reported outcomes as part of their baseline and post- treatment follow up. The clinical outcomes of individual patients will be monitored for up to 5 years.