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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12620000886987
Ethics application status
Approved
Date submitted
1/07/2020
Date registered
8/09/2020
Date last updated
9/01/2023
Date data sharing statement initially provided
8/09/2020
Date results information initially provided
9/01/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Total Ankle Arthroplasty Outcomes Study (TAAOS): Assessment of patient-reported measures and clinical outcomes following total ankle arthroplasty
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Scientific title
Patient reported outcome measures, satisfaction and rates of adverse events following total joint arthroplasty in end-stage ankle osteoarthritis - An observational cohort study
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Secondary ID [1]
301612
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None
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Universal Trial Number (UTN)
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Trial acronym
TAAOS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ankle osteoarthritis
317993
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Ankle trauma resulting in secondary ankle osteoarthritis
317994
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Total ankle arthroplasty
318501
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Condition category
Condition code
Musculoskeletal
316026
316026
0
0
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Osteoarthritis
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Musculoskeletal
316027
316027
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0
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Other muscular and skeletal disorders
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Surgery
316507
316507
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0
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Other surgery
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Population : Patients presenting with end-stage pathologies of the ankle and referred to specialist orthopaedic review
Exposure: Primary total ankle arthroplasty (TAA) with the Zimmer Biomet Trabecular Metalâ„¢ Total Ankle
Retrospective data will be extracted from medical records of patients who underwent a primary total ankle arthroplasty procedure between September 2016 and February 2020 under the provision of the participating orthopaedic surgeons. Data collected will include clinical, demographic, pathological and treatment data collected for TAA patients as part of the standard clinical pathway. Baseline patient reported outcome measures (PROMs) and occurrence of complications will also be retrospectively retrieved from the surgeons' practice management systems.
For the purpose of the study, participants will be asked to report their satisfaction with the TAA surgery and latest health status via the administration of a PROMs questionnaire pack at a single follow up timepoint. It is estimated the questionnaires will take approximately 20 minutes to complete. Follow up data will be reported at up to 4 years post-operatively, depending on the participant surgery dates.
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Intervention code [1]
317915
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Patient-reported pain, symptoms, activities of daily living, sport and recreation function and quality of life as assessed by aggregated Foot and Ankle Outcome (FAOS) score.
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Assessment method [1]
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Timepoint [1]
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Baseline (pre-treatment); latest follow up (up to 4 years post surgery).
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Primary outcome [2]
324233
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The incidence of adverse events (revisions, reoperations or complications).
Adverse events (complications, reoperations, revisions) will be determined and noted at the post-treatment clinical follow up with the treating surgeon via clinical assessment.
Complications may include delayed wound healing, wound infections or periprosthetic fractures determined through radiological investigations. Complications resulting in reoperations or revision surgery will be stratified using the coding guidelines proposed by the Canadian Orthopedic Foot and Ankle Society (COFAS) Ankle-Arthritis Study Group.
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Assessment method [2]
324233
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Timepoint [2]
324233
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up to 90 days following treatment
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Primary outcome [3]
324647
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Health related quality of life as assessed using the EQ5D-5L score
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Assessment method [3]
324647
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Timepoint [3]
324647
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Baseline (pre-treatment); latest follow up (up to 4 years post surgery).
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Secondary outcome [1]
384122
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Patient satisfaction as assessed by the satisfaction item within the MODEM's questionnaire
(primary outcome)
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Assessment method [1]
384122
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Timepoint [1]
384122
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Assessed at a single point - latest follow up (up to 4 years post surgery).
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Eligibility
Key inclusion criteria
Adults (>18y) diagnosed with end-stage osteoarthritis of the ankle by the principal investigators/participating consultant orthopaedic surgeons
Electing to undergo primary surgical TAA with the Zimmer Biomet Trabecular Metalâ„¢ Total Ankle by principal investigators/participating consultant orthopaedic surgeons
Baseline clinical history and questionnaires are available for the patient in the practice management system
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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 (e.g., schizophrenia, dementia, Alzheimer's Disease, personality disorder).
Revocation of consent for research use of personal data.
Revision TAA
Primary cases with a non-Zimmer implant OR performed in the public hospital
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Both
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Statistical methods / analysis
A priori calculation has been completed to assess and confirm that the clinic flow of TAA procedures at the principal investigators clinic provides sufficient sample size based on a rule of thumb of 10 failure events per variable entered into the model (Vittinghoff & McCulloch, 2007), assuming a failure rate of 40%.
The initial data analysis process will involve an assessment of the quality of data within the dataset using an outlier and distribution analysis. For the cohort analysis, a STROBE diagram (von Elm et al., 2007) will be compiled to indicate the analysis workflow, with reasons for data exclusion/withdrawal and rates of study participation and compliance with follow up outcomes.
Priority predictor variables for inclusion into the starting model will be identified and a multivariable stepwise logistic regression will be used to establish associations between predictors and probability of success/failure.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
14/09/2020
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Actual
12/10/2020
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Date of last participant enrolment
Anticipated
30/06/2022
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Actual
5/11/2020
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Date of last data collection
Anticipated
30/06/2022
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Actual
7/04/2021
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Sample size
Target
100
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Accrual to date
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Final
84
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
30635
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2065 - Wollstonecraft
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Funding & Sponsors
Funding source category [1]
306043
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Charities/Societies/Foundations
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Name [1]
306043
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The Friends of the Mater Foundation
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Address [1]
306043
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PO Box 958, North Sydney, NSW 2059 Australia
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Country [1]
306043
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Australia
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Primary sponsor type
Individual
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Name
Dr Andrew Wines
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Address
North Sydney Orthopaedic and Sports Medicine Centre
Suite 2, Mater Clinic. 25 Rocklands Road Wollstonecraft NSW 2065
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Country
Australia
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Secondary sponsor category [1]
306505
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Individual
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Name [1]
306505
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Dr Michael Symes
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Address [1]
306505
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St George Private Consulting Suites
Suite 201, 131 Princess Highway, Kogarah, NSW, 2217
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Country [1]
306505
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Australia
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Other collaborator category [1]
281372
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Individual
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Name [1]
281372
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Corey Scholes
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Address [1]
281372
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EBM Analytics
119 Willoughby Road, Crows Nest, 2065, New South Wales
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Country [1]
281372
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306270
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St Vincent's Hospital Sydney Human Research Ethics Committee
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Ethics committee address [1]
306270
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St Vincent’s Hospital Translational Research Centre
97-105 Boundary Street, Darlinghurst NSW 2010
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Ethics committee country [1]
306270
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Australia
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Date submitted for ethics approval [1]
306270
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30/06/2020
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Approval date [1]
306270
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06/08/2020
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Ethics approval number [1]
306270
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Human Research Ethics Application (HREA): 2020/ETH01444.
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Summary
Brief summary
The aim of this study is to investigate clinical and patient reported outcomes following total ankle arthroplasty (TAA). The study will comprise a consecutive observational cohort with retrospective and prospective study design.
Recruitment will include patients who have presented with ankle pathology to the principal investigators, Dr Andrew Wines and Dr Michael Symes, and elected to undergo TAA procedure. Patients will be presented with a Participant Information Sheet to inform them of the nature of the study and will be given an opportunity to provide informed consent for collection of their clinical data for research purposes via an opt-in approach.
The data collection process will involve retrospective chart review and collection of patient demographic, treatment and clinical data as well as patient reported outcome scores collected routinely as part of the standard clinical pathway at the baseline presentation. Consenting patients will also be requested to complete a set of questionnaires (FAOS, satisfaction) to enable evaluation of patient reported outcomes as part of the post- treatment follow up.
Aggregated pooled results will be deidentified, analysed and reported in the form of a manuscript for publication in a peer-review journal.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
103310
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Dr Andrew Wines
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Address
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Primary clinic location for Dr Wines:
North Sydney Orthopaedic and Sports Medicine Centre
Suite 2, Mater Clinic 25 Rocklands Road Wollstonecraft NSW 2065
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Country
103310
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Australia
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Phone
103310
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+61294090563
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Fax
103310
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Email
103310
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[email protected]
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Contact person for public queries
Name
103311
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Dr Michael Symes
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Address
103311
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Clinic location for Dr Symes:
St George Private Specialist Consulting Suites
Suite 5, Level 2, 19 Kensington Street, Kogarah, NSW, 2217
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Country
103311
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Australia
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Phone
103311
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+61 295874720
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Fax
103311
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Email
103311
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[email protected]
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Contact person for scientific queries
Name
103312
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Dr Corey Scholes
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Address
103312
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EBM Analytics; 119 Willoughby Road, Crows Nest, NSW, 2065
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Country
103312
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Australia
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Phone
103312
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+61299563800
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Fax
103312
0
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Email
103312
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Published online December 15, 2022 Clugston E, ...
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Documents added automatically
No additional documents have been identified.
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