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SMART-KNEE External Validation Study: New Zealand

Patient-focused prognostic tools used to predict outcomes in Total Knee Arthroplasty: A New Zealand external validation study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621001687886
Enrollment
17
Registered
2021-12-10
Start date
2022-04-02
Completion date
2023-01-31
Last updated
2022-12-05

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

Conditions

None listed

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.

Interventions

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.

Sponsors

Dr Michael English
Lead SponsorIndividual

Eligibility

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

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026