Knee Osteoarthritis, Total Knee Arthroplasty
Conditions
Keywords
Total knee arthroplasty, Prediction model, Deep neural network, Instrumented insole
Brief 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.
Detailed description
This study investigates predictive factors associated with postoperative improvement in both patient-reported outcomes and performance-based mobility measures among individuals undergoing total knee arthroplasty. Participants from two centers-Yongin Severance Hospital and Gachon University Gil Medical Center-will undergo preoperative collection of demographic data, body composition, muscle strength, comorbidity profiles, radiographic Kellgren-Lawrence grade, and wearable insole-derived gait data during the Timed Up and Go Test (TUGT). Postoperative outcomes at six weeks will include Western Ontario and McMaster Universities Arthritis Index (WOMAC) and TUGT. Prediction models (linear regression, random forest, and deep neural network models) will be applied using consistent input variables. Model performance will be evaluated using accuracy and Receiver Operating Characteristic-Area Under the Curve (ROC-AUC). This study does not involve any therapeutic intervention and poses minimal risk.
Interventions
OTHERInstrumented 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.
Sponsors
Yonsei University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go Test (TUGT) Improvement | Preoperative baseline; postoperative 6 weeks, 3 months, 6 months, and 12 months | Improvement defined as a decrease in TUGT completion time from baseline (binary). |
Countries
South Korea
Contacts
CONTACTNa Young Kim, MD, PhD
CONTACTSeung Ick Choi
PRINCIPAL_INVESTIGATORNa Young Kim, MD, PhD
Severance Hospital
Outcome results
None listed