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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TKA Patients | Participants scheduled for primary unilateral total knee arthroplasty at either Yongin Severance Hospital or Gachon University Gil Medical Center. No intervention is assigned; all data are collected as part of observational evaluation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Instrumented Insole Gait Assessment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) Improvement | 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). | Preoperative baseline; postoperative 6 weeks, 3 months, 6 months, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go Test (TUGT) Improvement | Improvement defined as a decrease in TUGT completion time from baseline (binary). | Preoperative baseline; postoperative 6 weeks, 3 months, 6 months, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with knee osteoarthritis undergoing primary total knee arthroplasty at two hospitals in South Korea.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Na Young Kim, MD, PhD | Contact | +82 010 9127 4482 | kny8452@yuhs.ac | |
| Seung Ick Choi | Contact | +82 010 8821 5297 | rehab1@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Na Young Kim, MD, PhD | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yongin Severance Hospital | Recruiting | Yongin-si | Gyeonggi-do | 16995 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37883429 | Background | Srivastava AK; Surgical Management of Osteoarthritis of the Knee Work Group, Staff of the American Academy of Orthopaedic Surgeons. American Academy of Orthopaedic Surgeons Clinical Practice Guideline Summary of Surgical Management of Osteoarthritis of the Knee. J Am Acad Orthop Surg. 2023 Dec 15;31(24):1211-1220. doi: 10.5435/JAAOS-D-23-00338. Epub 2023 Oct 24. | |
| 31888943 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2025 | Jan 18, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| D012216 |
| Rheumatic Diseases |