RecruitingACTRN12620000796987

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


Sponsor

Dr Sam Martin

Enrollment

5,000 participants

Start Date

Oct 21, 2020

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This is a registry study — not a treatment trial — designed to track the outcomes of people undergoing hip or knee joint replacement surgery at clinics in regional Australia. The goal is to better understand what factors predict a good result after joint replacement, including things like age, other health conditions, the type of surgery, and how patients rated their own pain and function before the operation. Participants will complete questionnaires before their surgery and at follow-up appointments over the next two years, covering topics like pain, movement, ability to kneel, quality of life, and whether their expectations were met. This information will help surgeons and healthcare planners understand how to improve joint replacement outcomes, particularly in regional areas where access to specialist care may differ from city centres. You may be eligible if you have been diagnosed with hip or knee arthritis and are seeing one of the participating orthopaedic surgeons at their consulting rooms. There are very few exclusions — essentially anyone 18 or older with hip or knee arthritis who is able to complete questionnaires can participate. This study involves no extra procedures — just questionnaires on top of your usual care.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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/ma

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)

NSW, Australia

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ACTRN12620000796987


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