Instrumented Insole Gait Assessment: Participants undergo gait assessment using an instrumented insole system during the Timed Up and Go Test. The device is used solely for data collection and does not provide therapeutic intervention.
Study summary
This multicenter prospective observational study aims to evaluate whether preoperative clinical variables and wearable sensor-derived gait features can predict postoperative improvement after total knee arthroplasty (TKA). Participants will undergo standardized gait assessments using instrumented insoles and complete validated patient-reported outcome measures (PROMs). Prediction models including linear regression, random forest, and deep neural networks will be applied and their performance compared.
Eligibility
Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age ≥ 19 years
* Diagnosed with knee osteoarthritis (Kellgren-Lawrence grade 1-4)
* Scheduled for primary Total Knee Arthroplasty (TKA) at either study site
* Able to walk independently on level ground (Functional Ambulation Categories, FAC ≥ 3)
Exclusion Criteria:
* Cancellation of scheduled TKA
* History of TKA on the same knee
* Neurological or musculoskeletal disorders affecting gait
* Pregnancy or possibility of pregnancy
* Any condition deemed inappropriate for study participation by the investigator
Primary outcome measure(s)
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Improvement — Preoperative baseline; postoperative 6 weeks, 3 months, 6 months, and 12 months Improvement in patient-reported symptoms as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
The WOMAC is a validated patient-reported outcome measure consisting of 24 items assessing pain (5 items), stiffness (2 items), and physical function (17 items). Each item is scored on a 5-point Likert scale (0-4), resulting in a total score ranging from 0 to 96, where higher scores indicate worse pain, stiffness, and functional limitation, and lower scores indicate better clinical status.
Postoperative improvement is defined as a decrease of ≥15 points in the WOMAC total score compared with the preoperative baseline, corresponding to the minimal clinically important difference (MCID). Participants will be classified as "improved" or "not improved" based on this criterion (binary outcome).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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