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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000072718
Acronym
PROTO-KNEE Trial (Prognostic Tool in Total Knee Arthroplasty Trial)
Enrollment
213
Registered
2022-01-21
Start date
2022-07-12
Completion date
2022-12-15
Last updated
2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 sec

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.

Sponsors

The University Of Melbourne
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 13, 2026