Prediction of Postoperative Outcomes After TKA Using Instrumented Insoles and DNN

Yonsei University

Status: Enrolling

Conditions: Knee Osteoarthritis; Total Knee Arthroplasty

Treatments: Other: Instrumented Insole Gait Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT07367789

GBIRB2025-324

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

TKA Patients

Description:

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.

Treatment:

Other: Instrumented Insole Gait Assessment