NCT07367789

Prediction of Postoperative Outcomes After TKA Using Instrumented Insoles and DNN

Prediction of Patient-reported Outcome Measure and Performance-based Measure After Total Knee Arthroplasty Using Instrumented Insoles and Deep Neural Networks

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Osteoarthritis
• Total Knee Arthroplasty

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

1 site across 1 country: South Korea