Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000796987
Ethics application status
Approved
Date submitted
17/06/2020
Date registered
7/08/2020
Date last updated
9/01/2023
Date data sharing statement initially provided
7/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Arthroplasty Outcomes in Regional Australia (AORA) A clinical quality registry of patients with hip and knee arthritis treated in a regional area
Scientific title
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
Secondary ID [1] 301544 0
None
Universal Trial Number (UTN)
U1111-1253-7426
Trial acronym
AORA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Arthritis 317904 0
Knee arthritis 317905 0
total knee replacement 318205 0
total hip replacement 318206 0
Condition category
Condition code
Musculoskeletal 315943 315943 0 0
Osteoarthritis
Musculoskeletal 315944 315944 0 0
Other muscular and skeletal disorders
Surgery 316213 316213 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
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.
Intervention code [1] 317846 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324145 0
Complication occurrence as determined by clinical examination, observed by surgeon or reported by the patient. Includes intraoperative complications such as bleeding, component failure; and complications presenting following treatment including nerve damage, malpositioning of hardware components.
Timepoint [1] 324145 0
Intraoperative, once at 2-6 weeks following definitive treatment (primary endpoint), spontaneous reports up to 2 years following treatment.
Secondary outcome [1] 383863 0
Pain, activities of daily living and quality of life as measured by KOOS-12 scores (composite measure)
Timepoint [1] 383863 0
baseline; once at 2-6 weeks; 3 months; 6 months; 12 months; 24 months following definitive treatment
Secondary outcome [2] 383864 0
Pain, activities of daily living and quality of life as measured by HOOS-12 scores (composite measure)
Timepoint [2] 383864 0
baseline; once at 2-6 weeks; 3 months; 6 months; 12 months; 24 months following definitive treatment
Secondary outcome [3] 383865 0
Patient expectations of treatment outcomes, as measured by the MODEMs expectations scale
Timepoint [3] 383865 0
baseline; 6 months; 12 months; 24 months following definitive treatment
Secondary outcome [4] 383866 0
Patient satisfaction (graded on a 4 point likert scale)
Timepoint [4] 383866 0
12 months; 24 months following definitive treatment
Secondary outcome [5] 383867 0
Clinician rated kneeling ability (clinician-rated; scored as yes/no)
Timepoint [5] 383867 0
once at 2-6 weeks following definitive treatment
Secondary outcome [6] 384555 0
Patient-rated kneeling ability (measured by item SP5 of the full version of KOOS questionnaire)
Timepoint [6] 384555 0
3 months; 6 months; 12 months; 24 months following definitive treatment
Secondary outcome [7] 384557 0
Veterans Rand-12 Quality of life questionnaire
Timepoint [7] 384557 0
Baseline only

Eligibility
Key inclusion criteria
Diagnosed with knee or hip arthritis
Undergoing consultation by the investigators/consultant orthopaedic surgeons
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinically diagnosed mental/neurological illness (indicated on GP referral, or identified through secondary referral to psychiatric/neurological specialist) that precludes retrieval of patient feedback via interview, paper or electronic questionnaire

Revocation of consent for use of personal data for research purposes.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The sample size will reflect the clinical flow of knee and hip arthroplasty surgeries performed by the participating surgeons. Sample size calculations were based on a rule of thumb of 10 treatment failure events per variable entered into a binary logistic regression model, assuming a clinical failure of 25% (hip) or 20% (knee) at up to 2 years followup. Failure rates were estimated from revision rates reported in the AOANJRR for the surgeon's most commonly used hip/knee implants, and rates of unsatisfied patients reported in relevant peer-reviewed literature. Binary logistic regression will be used to identify preoperative and early intraoperative or post-treatment characteristics affecting patient reported outcomes, and rates of treatment failure.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/08/2020
Actual
21/10/2020
Date of last participant enrolment
Anticipated
25/08/2025
Actual
Date of last data collection
Anticipated
23/08/2027
Actual
Sample size
Target
5000
Accrual to date
1726
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 30578 0
2460 - Grafton

Funding & Sponsors
Funding source category [1] 305973 0
Self funded/Unfunded
Name [1] 305973 0
Dr Sam Martin
Country [1] 305973 0
Australia
Primary sponsor type
Individual
Name
Dr Sam Martin
Address
Specialist Orthopaedic Centre, 1/12 King Street, Grafton, NSW 2460
Country
Australia
Secondary sponsor category [1] 306431 0
Individual
Name [1] 306431 0
Dr Michel Genon
Address [1] 306431 0
Specialist Orthopaedic Centre, 1/12 King Street, Grafton, NSW 2460
Country [1] 306431 0
Australia
Other collaborator category [1] 281368 0
Commercial sector/Industry
Name [1] 281368 0
EBM Analytics
Address [1] 281368 0
119 Willoughby Road Crows Nest, NSW 2065
Country [1] 281368 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306213 0
North Coast NSW HREC
Ethics committee address [1] 306213 0
PO Box 821 Murwillumbah NSW 2484
Ethics committee country [1] 306213 0
Australia
Date submitted for ethics approval [1] 306213 0
09/06/2020
Approval date [1] 306213 0
21/10/2020
Ethics approval number [1] 306213 0
2020/ETH01498

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103118 0
Dr Sam Martin
Address 103118 0
Specialist Orthopaedic Centre, 1/12 King Street, Grafton, NSW 2460
Country 103118 0
Australia
Phone 103118 0
+61 266750737
Fax 103118 0
Email 103118 0
[email protected]
Contact person for public queries
Name 103119 0
Dr Dr Sam Martin
Address 103119 0
Specialist Orthopaedic Centre, 1/12 King Street, Grafton, NSW 2460
Country 103119 0
Australia
Phone 103119 0
+61 266750737
Fax 103119 0
Email 103119 0
[email protected]
Contact person for scientific queries
Name 103120 0
Dr Sam Martin
Address 103120 0
Specialist Orthopaedic Centre, 1/12 King Street, Grafton, NSW 2460
Country 103120 0
Australia
Phone 103120 0
+61 266750737
Fax 103120 0
Email 103120 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.