ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Knee Osteoarthritis

Condition category

Condition code

Musculoskeletal

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Accuracy of the SMART-KNEE tool in predicting outcomes of patients post unilateral primary total knee arthroplasty via the VR-12 form

Timepoint [1]

12 months

Secondary outcome [1]

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]

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?

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

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Northland and Bay of Plenty

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Wishbone Foundation

Address [1]

Wishbone Foundation c/o NZOA Level 12 Ranchhod Tower 39 The Terrace Wellington, 6011

Country [1]

New Zealand

Primary sponsor type

Individual

Name

Dr Michael English

Address

Whangarei Hospital
Maunu Road
Whangarei
0148

Country

New Zealand

Secondary sponsor category [1]

Individual

Name [1]

Mr Marc Hirner

Address [1]

Whangarei Hospital Maunu Road Whangarei 0148

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

HDEC NZ

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

01/12/2021

Approval date [1]

14/12/2021

Ethics approval number [1]

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

Dr Michael English

Address

Whangarei Hospital Maunu Road Whangarei 0148

Country

New Zealand

Phone

+64 273635021

Fax

[email protected]

Contact person for public queries

Name

Michael English

Address

Whangarei Hospital Maunu Road Whangarei 0148

Country

New Zealand

Phone

+64 273635021

Fax

[email protected]

Contact person for scientific queries

Name

Michael English

Address

Whangarei Hospital Maunu Road Whangarei 0148

Country

New Zealand

Phone

+64 273635021

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Only researchers who provide a methodologically sound proposal on a case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?

• All of the individual participant date after de-identification underlying published results

What types of analyses could be done with individual participant data?

• only to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?

From:
After publication, and be available for 5 years

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• access subject to approvals by Principal Investigator
[email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
14173	Study protocol					Study-related document.pdf
14174	Informed consent form					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.

Trial Review

Documents added manually

Documents added automatically