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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] 305336 0
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 323657 0
Condition category
Condition code
Musculoskeletal 321195 321195 0 0
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] 321746 0
Diagnosis / Prognosis
Intervention code [2] 322121 0
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] 329111 0
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] 329111 0
6 weeks, 12 weeks, and 6 months after using the PROTO-KNEE tool
Secondary outcome [1] 401503 0
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] 401503 0
Evaluating effect on willingness for surgery at 6 months after participant enrolment.

Secondary outcome [2] 404009 0
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] 404009 0
6 months after participant enrolment
Secondary outcome [3] 404515 0
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] 404515 0
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?
No
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
NA
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] 20632 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 35423 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 309705 0
Commercial sector/Industry
Name [1] 309705 0
HCF Research Foundation
Country [1] 309705 0
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] 311144 0
None
Name [1] 311144 0
Address [1] 311144 0
Country [1] 311144 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309468 0
Human Research Ethics Committee, St Vincent's Hospital Melbourne
Ethics committee address [1] 309468 0
41 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 309468 0
Australia
Date submitted for ethics approval [1] 309468 0
03/11/2021
Approval date [1] 309468 0
21/12/2021
Ethics approval number [1] 309468 0
HREC 285/21
Ethics committee name [2] 309774 0
Office of Research Ethics and Integrity, University of Melbourne
Ethics committee address [2] 309774 0
Level 5, Allan Gilbert Building
161 Barry Street
PARKVILLE VICTORIA 3010
Ethics committee country [2] 309774 0
Australia
Date submitted for ethics approval [2] 309774 0
01/12/2021
Approval date [2] 309774 0
Ethics approval number [2] 309774 0

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 114254 0
Dr Christopher Schilling
Address 114254 0
University of Melbourne
Department of Surgery
Swanston Street
PARKVILLE VIC 3052
Country 114254 0
Australia
Phone 114254 0
+61 0438104413
Fax 114254 0
Email 114254 0
[email protected]
Contact person for public queries
Name 114255 0
Lauren Patten
Address 114255 0
St Vincent's Hospital
Department of Orthopaedics
Level 3, Daly Wing
35 Victoria Parade
FITZROY VIC 3065
Country 114255 0
Australia
Phone 114255 0
+61 3 92315387
Fax 114255 0
Email 114255 0
[email protected]
Contact person for scientific queries
Name 114256 0
Yushy Zhou
Address 114256 0
University of Melbourne
Department of Surgery
Swanston Street
PARKVILLE VIC 3052
Country 114256 0
Australia
Phone 114256 0
+61 413676371
Fax 114256 0
Email 114256 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
13957Study 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
SourceTitleYear of PublicationDOI
EmbaseEvaluating willingness for surgery using the SMART Choice (Knee) patient prognostic tool for total knee arthroplasty: study protocol for a pragmatic randomised controlled trial.2022https://dx.doi.org/10.1186/s12891-022-05123-0
N.B. These documents automatically identified may not have been verified by the study sponsor.