Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001687886
Ethics application status
Approved
Date submitted
21/11/2021
Date registered
10/12/2021
Date last updated
30/11/2022
Date data sharing statement initially provided
10/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
SMART-KNEE External Validation Study: New Zealand
Scientific title
Patient-focused prognostic tools used to predict outcomes in Total Knee Arthroplasty: A New Zealand external validation study
Secondary ID [1] 305853 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 324389 0
Condition category
Condition code
Musculoskeletal 321873 321873 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
For patients undergoing unilateral primary total knee arthroplasty in Northland and Bay of Plenty, New Zealand, we will be recording basic demographic data and VR-12 and EQ-5D-3L forms pre surgery, 6months and 12months post surgery, in order to retrospectively use the SMART-KNEE and After my surgery prognostic tools. Based upon these results, we can then possibly validate these tools for use in New Zealand.
Intervention code [1] 322248 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329630 0
Accuracy of the SMART-KNEE tool in predicting outcomes of patients post unilateral primary total knee arthroplasty via the VR-12 form
Timepoint [1] 329630 0
12 months
Secondary outcome [1] 403218 0
Accuracy of the After my Surgery tool in predicting outcomes of patients post unilateral primary total knee arthroplasty via the EQ-5D-3L form
Timepoint [1] 403218 0
6 months

Eligibility
Key inclusion criteria
• Diagnosed with knee OA
• Imminently about to undergo primary unilateral TKA (by imminently, we mean is within 2 to 3 weeks of surgery including up to and on the day of surgery)
• Are willing and able to complete online PROMs tools
• Able to provide informed consent to participate
• Are available to be followed up for the duration of the study
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Source of knee symptoms is considered to be from any cause other than knee OA eg, rheumatoid arthritis, hip osteoarthritis, referred lower back pain, post traumatic arthritis, previous septic arthritis of the knee etc.
• Are undergoing bilateral TKA, revision TKA, unicondylar knee arthroplasty (UKA), or patellofemoral arthroplasty
• Significant bilateral knee symptoms
• Intra-articular injection in the affected knee within the last 3 months
• Patients younger than 45years

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A power analysis calculation has been performed to estimate the sample size for this study. We used preliminary results from the developers of SMART-KNEE to estimate effect size. Standard values for alpha at 0.05 and beta at 0.8 were used to scale our calculation. We predict that approximately 200 participants will be required to provide a meaningful outcome to this study.
Once the study follow up period is completed, we aim to retrospectively use the tools on the collected patient data to determine the accuracy of their predictions.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/01/2022
Actual
2/04/2022
Date of last participant enrolment
Anticipated
31/01/2023
Actual
Date of last data collection
Anticipated
31/01/2024
Actual
Sample size
Target
200
Accrual to date
17
Final
Recruitment outside Australia
Country [1] 24344 0
New Zealand
State/province [1] 24344 0
Northland and Bay of Plenty

Funding & Sponsors
Funding source category [1] 310206 0
Charities/Societies/Foundations
Name [1] 310206 0
Wishbone Foundation
Country [1] 310206 0
New Zealand
Primary sponsor type
Individual
Name
Dr Michael English
Address
Whangarei Hospital
Maunu Road
Whangarei
0148
Country
New Zealand
Secondary sponsor category [1] 311298 0
Individual
Name [1] 311298 0
Mr Marc Hirner
Address [1] 311298 0
Whangarei Hospital
Maunu Road
Whangarei
0148
Country [1] 311298 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309886 0
HDEC NZ
Ethics committee address [1] 309886 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 309886 0
New Zealand
Date submitted for ethics approval [1] 309886 0
01/12/2021
Approval date [1] 309886 0
14/12/2021
Ethics approval number [1] 309886 0

Summary
Brief summary
We know that total knee arthroplasty (replacement) can be an effective procedure for patients suffering from knee osteoarthritis in improving their quality of life. However, up to 20percent of patients can remain unsatisfied after their procedure. The decision to undergo total knee arthroplasty can be complex and intimidating for an individual patient.
This study aims to validate the SMART-KNEE tool in a New Zealand population. The SMART-KNEE tool is a prognostic tool that provides individual patients a prediction of their outcome following total knee arthroplasty in the form of a likelihood score. It has been developed by the University of Melbourne in Australia.
It is patient focused, i.e., it is designed to only require input/data from a patient and not rely on any information a clinician may have to provide. It compares the patient’s own responses to a large pool of similar patients who have already undergone total knee arthroplasty whose outcomes we already know through a large managed database. It is designed to reflect a minimally important difference for the patient.
A similar tool, the ‘After my surgery’ tool developed by York University in the UK also exists. Likewise, this tool has also not been validated in a New Zealand population. We will also be aiming to validate this tool as well in our study as a secondary objective.
To our knowledge, no such tool has been validated or created in a New Zealand population.
These tools can help inform a patient prior to undergoing total knee arthroplasty by telling them how likely they are to benefit. This comes in the form of percentages of likelihood to benefit, have no change, or be worse off after knee arthroplasty. This can add to the patient’s understanding of whether they wish to undergo this procedure, but also help manage their expectations of it.
This study will collect the data necessary to use these two tools for approximately 200 New Zealand based participants who are about to undergo total knee arthroplasty. We will then follow their outcomes be recollecting the necessary quality of life surveys. We can then retrospectively use the tools and see if their predictions are accurate. If they prove to be accurate, then we can validate them and recommend them for wider use.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115730 0
Dr Michael English
Address 115730 0
Whangarei Hospital
Maunu Road
Whangarei
0148
Country 115730 0
New Zealand
Phone 115730 0
+64 273635021
Fax 115730 0
Email 115730 0
michael.english@northlanddhb.org.nz
Contact person for public queries
Name 115731 0
Dr Michael English
Address 115731 0
Whangarei Hospital
Maunu Road
Whangarei
0148
Country 115731 0
New Zealand
Phone 115731 0
+64 273635021
Fax 115731 0
Email 115731 0
michael.english@northlanddhb.org.nz
Contact person for scientific queries
Name 115732 0
Dr Michael English
Address 115732 0
Whangarei Hospital
Maunu Road
Whangarei
0148
Country 115732 0
New Zealand
Phone 115732 0
+64 273635021
Fax 115732 0
Email 115732 0
michael.english@northlanddhb.org.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant date after de-identification underlying published results
When will data be available (start and end dates)?
After publication, and be available for 5 years
Available to whom?
Only researchers who provide a methodologically sound proposal on a case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator
michael.english@northlanddhb.org.nz


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14173Study protocol    383168-(Uploaded-09-12-2021-08-05-45)-Study-related document.pdf
14174Informed consent form    383168-(Uploaded-09-12-2021-08-08-01)-Study-related document.pdf



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.