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
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
Secondary ID [1] 301612 0
None
Universal Trial Number (UTN)
Trial acronym
TAAOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankle osteoarthritis 317993 0
Ankle trauma resulting in secondary ankle osteoarthritis 317994 0
Total ankle arthroplasty 318501 0
Condition category
Condition code
Musculoskeletal 316026 316026 0 0
Osteoarthritis
Musculoskeletal 316027 316027 0 0
Other muscular and skeletal disorders
Surgery 316507 316507 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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 Metal™ 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.
Intervention code [1] 317915 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324232 0
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.
Timepoint [1] 324232 0
Baseline (pre-treatment); latest follow up (up to 4 years post surgery).
Primary outcome [2] 324233 0
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.
Timepoint [2] 324233 0
up to 90 days following treatment
Primary outcome [3] 324647 0
Health related quality of life as assessed using the EQ5D-5L score
Timepoint [3] 324647 0
Baseline (pre-treatment); latest follow up (up to 4 years post surgery).
Secondary outcome [1] 384122 0
Patient satisfaction as assessed by the satisfaction item within the MODEM's questionnaire
(primary outcome)
Timepoint [1] 384122 0
Assessed at a single point - latest follow up (up to 4 years post surgery).

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 Metal™ Total Ankle by principal investigators/participating consultant orthopaedic surgeons
Baseline clinical history and questionnaires are available for the patient in the practice management system
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 (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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/09/2020
Actual
12/10/2020
Date of last participant enrolment
Anticipated
30/06/2022
Actual
5/11/2020
Date of last data collection
Anticipated
30/06/2022
Actual
7/04/2021
Sample size
Target
100
Accrual to date
Final
84
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 30635 0
2065 - Wollstonecraft

Funding & Sponsors
Funding source category [1] 306043 0
Charities/Societies/Foundations
Name [1] 306043 0
The Friends of the Mater Foundation
Country [1] 306043 0
Australia
Primary sponsor type
Individual
Name
Dr Andrew Wines
Address
North Sydney Orthopaedic and Sports Medicine Centre
Suite 2, Mater Clinic. 25 Rocklands Road Wollstonecraft NSW 2065
Country
Australia
Secondary sponsor category [1] 306505 0
Individual
Name [1] 306505 0
Dr Michael Symes
Address [1] 306505 0
St George Private Consulting Suites
Suite 201, 131 Princess Highway, Kogarah, NSW, 2217
Country [1] 306505 0
Australia
Other collaborator category [1] 281372 0
Individual
Name [1] 281372 0
Corey Scholes
Address [1] 281372 0
EBM Analytics
119 Willoughby Road, Crows Nest, 2065, New South Wales
Country [1] 281372 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306270 0
St Vincent's Hospital Sydney Human Research Ethics Committee
Ethics committee address [1] 306270 0
St Vincent’s Hospital Translational Research Centre
97-105 Boundary Street, Darlinghurst NSW 2010
Ethics committee country [1] 306270 0
Australia
Date submitted for ethics approval [1] 306270 0
30/06/2020
Approval date [1] 306270 0
06/08/2020
Ethics approval number [1] 306270 0
Human Research Ethics Application (HREA): 2020/ETH01444.

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103310 0
Dr Andrew Wines
Address 103310 0
Primary clinic location for Dr Wines:
North Sydney Orthopaedic and Sports Medicine Centre
Suite 2, Mater Clinic 25 Rocklands Road Wollstonecraft NSW 2065
Country 103310 0
Australia
Phone 103310 0
+61294090563
Fax 103310 0
Email 103310 0
apw1307@bigpond.com
Contact person for public queries
Name 103311 0
Dr Michael Symes
Address 103311 0
Clinic location for Dr Symes:
St George Private Specialist Consulting Suites
Suite 5, Level 2, 19 Kensington Street, Kogarah, NSW, 2217
Country 103311 0
Australia
Phone 103311 0
+61 295874720
Fax 103311 0
Email 103311 0
drmichaelsymes@gmail.com
Contact person for scientific queries
Name 103312 0
Dr Corey Scholes
Address 103312 0
EBM Analytics; 119 Willoughby Road, Crows Nest, NSW, 2065
Country 103312 0
Australia
Phone 103312 0
+61299563800
Fax 103312 0
Email 103312 0
cscholes@ebma.com.au

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Published online December 15, 2022 Clugston E, ... [More Details]

Documents added automatically
No additional documents have been identified.