Arthroplasty Outcomes in Regional Australia (AORA) A clinical quality registry of patients with hip and knee arthritis treated in a regional area
A clinical quality registry investigating the occurrence of post-surgical complications and patient-reported outcomes in patients with hip and knee arthritis treated in a regional area
Dr Sam Martin
5,000 participants
Oct 21, 2020
Observational
Conditions
Summary
This is a prospective, observational registry-based study assessing outcomes of total knee and hip joint replacement surgery. The primary objective of this protocol is to determine predictors of patient outcomes collected routinely as part of the standard clinical pathway for lower limb arthroplasty performed by the participating surgeons. Predictors will include demographics, comorbidities, relevant clinical and operative details, and preoperative patient-reported pain and function measures including the Veterans-Rand 12-item quality of life questionnaire (VR-12), the Knee Osteoarthritis Outcome Score (12-item; KOOS-12), the Hip Osteoarthritis Outcome Score (12-item; HOOS-12), and the MODEMs patient expectations scale. Patient outcomes will include postoperative KOOS-12/HOOS-12 scores, self-rated kneeling ability, the postoperative component of the MODEMs expectations scale, patient satisfaction, and revisions or complications arising as a result of treatment. Recruitment will include all patients presenting with lower limb (knee or hip) pathology to the principal and associate investigators at their consulting rooms. Patients will undergo routine standard of care preoperative work-up, including the collection of demographic information, medical history, radiology, pathology, and functional analysis. Patients will in addition be requested to complete patient-reported outcome measures (PROMs) to enable evaluation of important surgical outcomes as part of the post-operative follow up. The outcomes of individual patients will be monitored up to 2 years postoperatively.
Eligibility
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Interventions
This registry will collate clinical information and patient-reported outcomes for private patients presenting with hip or knee arthritis, and determine the associated contributing patient/pathology/management factors at up to 2 years of follow-up. Patients will undergo consultation for diagnosis and treatment, including the collection of demographic data, patient medical history, radiological findings and diagnosis as per standards of care. Clinical outcomes at baseline and post treatment follow up will be assessed via completion of general health, expectation/satisfaction and pathology specific questionnaires. Patients will attend for follow-up visits as decided by the clinician on an individual basis, and those participating in the registry will complete questionnaires delivered electronically at pre-determined time points (dependent on questionnaire; includes pre-treatment, and 3, 6, 12 and 24 months following definitive treatment). Clinical information will be collected within the clinic practice management systems during consultation or follow up as per standard operative or nonoperative treatment pathways, and data from eligible patients collated within the AORA registry for subsequent review and analysis. Participants to the AORA 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 decline the use of their medical records and clinical information for the clinical registry.
Locations(1)
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ACTRN12620000796987