ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000072718

Ethics application status

Approved

Date submitted

22/11/2021

Date registered

21/01/2022

Date last updated

7/07/2023

Date data sharing statement initially provided

21/01/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Patient-Focused Prognostic Tool to Evaluate Willingness for Surgery in Total Knee Arthroplasty: A Randomised Controlled Trial (The Proto Knee Trial)

Scientific title

Patient-Focused Prognostic Tool to Evaluate Willingness for Surgery in Total Knee Arthroplasty: A Randomised Controlled Trial (The Proto Knee Trial)

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

PROTO-KNEE Trial (Prognostic Tool in Total Knee Arthroplasty Trial)

Linked study record

Health condition

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

Osteoarthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention here is a prognostic tool that predicts outcomes of total knee arthroplasty. Participants who are considerig total knee arthroplasty can use this tool to provide them a likelihood score of improvement/no change/deterioration after surgery. The tool uses machine learning algorithms to predict outcomes based on the St. Vincent's Hospital Melbourne Arthroplasty Registry (SMART) with over 7000 primary knee replacements.

For patients to use the tool, they will be directed to a secure online study portal. This will be require participants to login to the study portal with their participant credentials. The tool will ask patients to enter their age, gender, and Veterans-Rand 12 (VR-12) responses. The anticipated time to use the tool will be approximately 2 minutes. Participants who are allocated to the intervention arm of the trial will only use the tool once at the beginning of the study. The tool will provide participants with a display of "in 100 patients who are similar to you, XX noticed a significant improvement 1 year after surgery, and XX noticed no change or deterioration 1 year after surgery". As the tool will be housed on a study portal for the duration of the trial - information will be captured and saved to a local server based at the University of Melbourne, Victoria, Australia.

In the future (after the conclusion of the study), we aim to publish a public version of the PROTO-KNEE tool that will be freely available online. Patients will be able to access this tool without the need to login with credentials. This public version of the tool will not capture any data but simply present predictive information for patients to use.

Intervention code [1]

Diagnosis / Prognosis

Intervention code [2]

Treatment: Other

Comparator / control treatment

Control group in this study will be treatment as usual. This will be exactly the same care as participants in the intervention group, except without use of the predictive tool. Treatment as usual in this study will differ based on which hospital/health group each participant is recruited from. However, this will generally consist of orthopaedic follow up appointments, booking and proceeding of knee replacement if fit for surgery, usual medications, and primary health care.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome of this study is to evaluate the impact of the PROTO-KNEE tool use on willingness for TKA surgery for patients with knee OA. This will be measured with a binary question "are your knee symptoms so bothersome that you would be willing to undergo surgery if medically fit to do so? (Yes/No)"

Timepoint [1]

6 weeks, 12 weeks, and 6 months after using the PROTO-KNEE tool

Secondary outcome [1]

To determine the best timepoint on a patient's TKA journey for the prognostic tool to be used. This will be determined based on when tool use will maximally impact willingness for surgery. The reference point for the patient's TKA journey will be based on how long before or after a patient has first consulted with an Orthopaedic Surgeon.

Timepoint [1]

Evaluating effect on willingness for surgery at 6 months after participant enrolment.

Secondary outcome [2]

Evaluate the effect of the PROTO-KNEE on patient decision quality when considering surgery - using the Knee Osteoarthritis Decision Quality Instrument (K-DQI). Only participants in the intervention group (i.e. have used the PROTO-KNEE tool) will use this instrument.

The K-DQI aims to assess:
- Which aspects of decision-making matter most to the patient
- How well the patient is understanding the information provided, and
- The level of communication between the patient and clinician prior to decision-making.

Timepoint [2]

6 months after participant enrolment

Secondary outcome [3]

Evaluate the effect of the PROTO-KNEE on patient decision quality when considering surgery - using the SURE decision conflict screening tool. Only participants in the intervention group (i.e. have used the PROTO-KNEE tool) will use this instrument.

The SURE aims to assess decisional conflict through four questions:
- Do you feel sure about the best choice for you?
- Do you know the benefits and risk of each option for you?
- Are you clear about which benefits and risks matter the most for you?
- Do you have enough support and advice to make a choice?

Timepoint [3]

6 months after participant enrolment

Eligibility

Key inclusion criteria

Diagnosed with knee OA and are considering TKA

Considering primary and unilateral TKA

Have already trialled non-operative management for their knee symptoms

Are willing and able to use web or mobile phone based prognostic tool interfaces

Able to provide informed consent to participate and be followed up for the entire
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 e.g.
rheumatoid arthritis, hip osteoarthritis, referred lower back pain etc.

Are considering bilateral TKA, revision TKA, unicondylar knee arthroplasty (UKA),
or patellofemoral arthroplasty (PFA)

Unwilling to consider TKA despite being advised by the Orthopaedic Surgeon this
would be a reasonable management option for their knee symptoms

Prior history of septic arthritis in the affect knee

Significant bilateral knee symptoms

Intra-articular injection in the affected knee within the last 3 months

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

.Central randomisation by phone/fax/computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation through a computer random number generator.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

This is an exploratory study and hence sample size calculation was not possible. Instead, we used to recent studies in a similar field to perform a power calculation using standard alpha as 0.05 and beta as 0.8. The result showed a study that required approximately 200 participants in total. However, given this is an exploratory study, additional recruitment will be sought. Analysis of the study will be performed using descriptive statistics. Consultation with our Unit Biostatistician has already been sought, and the above plan is agreed.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/02/2022

Actual

12/07/2022

Date of last participant enrolment

Anticipated

31/12/2022

Actual

15/12/2022

Date of last data collection

Anticipated

1/02/2023

Actual

30/06/2023

Sample size

Target

200

Accrual to date

Final

213

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment hospital [1]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment postcode(s) [1]

3065 - Fitzroy

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

HCF Research Foundation

Address [1]

GPO Box 4242
SYDNEY NSW 2000

Country [1]

Australia

Primary sponsor type

University

Name

The University Of Melbourne

Address

Department of Surgery
Swanston Street
PARKVILLE VICTORIA 3052

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee, St Vincent's Hospital Melbourne

Ethics committee address [1]

41 Victoria Parade
Fitzroy VIC 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/11/2021

Approval date [1]

21/12/2021

Ethics approval number [1]

HREC 285/21

Ethics committee name [2]

Office of Research Ethics and Integrity, University of Melbourne

Ethics committee address [2]

Level 5, Allan Gilbert Building
161 Barry Street
PARKVILLE VICTORIA 3010

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

01/12/2021

Approval date [2]

Ethics approval number [2]

Summary

Brief summary

1 in 5 patients after total knee arthroplasty (TKA) are left feeling unsatisfied. Therefore, patient selection prior to TKA is critical. We have developed a prognostic tool that can predict outcomes after TKA before the patient undergoes surgery. Our tool (PROTO-KNEE) uses machine learning algorithms to predict TKA outcome before patients undergo surgery. Patients can use the tool by inputting their age, gender, and pre-operative quality of life (using a validated questionnaire) and the tool will predict their likelihood for improvement or no improvement after TKA. The study will evaluate this tool on patients decision making. In particular, we are interested to understand how this predictive tool influences a patient's willingness for surgery. Our hypothesis is that use of this tool will better inform patient decision making through individualised outcome prediction early in the TKA journey.

Trial website

Trial related presentations / publications

Public notes

Additional recruitment will be through the HCF (health insurance company) database of clients. It is not possible to select this as a recruitment site in Section 7. This will allow patients around Australia who are members of HCF that fit specific inclusion criteria to join the study.  All participants will be in Australia and subject to Australian laws around privacy and research integrity, and the database will be located in servers located in Victoria. .

Contacts

Principal investigator

Name

Dr Christopher Schilling

Address

University of Melbourne
Department of Surgery
Swanston Street
PARKVILLE VIC 3052

Country

Australia

Phone

+61 0438104413

Fax

chris.schilling@unimelb.edu.au

Contact person for public queries

Name

Lauren Patten

Address

St Vincent's Hospital
Department of Orthopaedics
Level 3, Daly Wing
35 Victoria Parade
FITZROY VIC 3065

Country

Australia

Phone

+61 3 92315387

Fax

patten.l@unimelb.edu.au

Contact person for scientific queries

Name

Yushy Zhou

Address

University of Melbourne
Department of Surgery
Swanston Street
PARKVILLE VIC 3052

Country

Australia

Phone

+61 413676371

Fax

yushy.zhou@student.unimelb.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

IPD in this trial must be attributed with private information (e.g. hospital number) so results can be linked to Registry data in a later study. Therefore, we will not be able to publish IPD for privacy reasons.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
13957	Study protocol				A publically available study protocol will be subm... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Evaluating willingness for surgery using the SMART Choice (Knee) patient prognostic tool for total knee arthroplasty: study protocol for a pragmatic randomised controlled trial.	2022	https://dx.doi.org/10.1186/s12891-022-05123-0

N.B. These documents automatically identified may not have been verified by the study sponsor.

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