RecruitingACTRN12620000331932

SOFARI Clinical Outcomes Registry

Sydney Orthopaedic Foot and Ankle Research Institute (SOFARI) Registry : A quality clinical outcomes registry of patients treated in private practice

Sponsor

Sydney Orthopaedic Foot and Ankle Research Institute (SOFARI)

Enrollment

50,000 participants

Start Date

Jun 1, 2020

Study Type

Observational

Conditions

Disorders of synovium or tendons of the ankle and foot Claw and hammertoe deformities Ingrowing nails Other pathologies of the ankle and foot Foot and ankle arthritis Hallux deformities Foot and ankle instability Osteochondritis dissecans of ankle and joints of foot Ankle arthrofibrosis Morton metatarsalgia

Summary

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Foot and ankle problems — from bunions and arthritis to tendon disorders and nerve pain — can significantly affect how you walk and your quality of life. This clinical registry tracks the outcomes of patients receiving treatment for a wide range of foot and ankle conditions at a specialist orthopaedic practice in Sydney, providing detailed long-term data on what works and what doesn't. As a registry study, there is no experimental treatment — participants simply receive the care that their surgeon recommends and complete questionnaires about their pain, function, and quality of life at baseline and at follow-up appointments over up to 5 years. The data helps clinicians understand real-world outcomes and improve future treatment decisions. You may be eligible if you are a private patient attending Drs Michael Symes or Andrew Wines for a foot or ankle condition. The registry uses an 'opt-out' consent approach — you receive an information sheet and are included unless you choose not to be. People with mental or neurological conditions that prevent completing questionnaires or those who revoke consent are excluded.

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Interventions

This registry will collate clinical information and patient-reported outcomes for private patients presenting with foot or ankle pathologies, and determine the associated specific patient/pathology/m

This registry will collate clinical information and patient-reported outcomes for private patients presenting with foot or ankle pathologies, and determine the associated specific patient/pathology/management factors at up to 2 years of follow-up. Participant involvement will be as per standards of care. Patients will undergo consultation for diagnosis and treatment of foot and ankle pathologies, including the collection of demographic data, patient medical history, radiological findings and diagnosis. Clinical outcomes at baseline and post treatment follow up will be assessed via completion of general health, expectation/satisfaction and region specific questionnaires. Clinical information will be collected within the clinic practice management systems during consultation or follow up as per standard treatment pathways, and collated within the SOFARI registry for subsequent review and analysis. Participants to the SOFARI clinical outcomes registry will be provided information stating the purpose of the clinical outcomes registry, and the inclusion of their clinical data for research and monitoring purposes. Patients will be provided an opportunity to actively consent or decline the use of their medical records and clinical information for the clinical registry.

Locations(1)

NSW, Australia

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ACTRN12620000331932