Prediction of Postoperative Outcomes After TKA Using Instrumented Insoles and DNN

January 18, 2026 updated by: Yonsei University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Na Young Kim, MD, PhD
  • Phone Number: +82 010 9127 4482
  • Email: kny8452@yuhs.ac

Study Contact Backup

  • Name: Seung Ick Choi
  • Phone Number: +82 010 8821 5297
  • Email: rehab1@yuhs.ac

Study Locations

  • South Korea
    • Gyeonggi-do
      • Yongin-si, Gyeonggi-do, South Korea, 16995
        • Recruiting
        • Yongin Severance Hospital
        • Contact:
          • Na Young Kim, MD, PhD
          • Phone Number: +82 010 9127 4482
          • Email: kny8452@yuhs.ac
        • Contact:
          • Seung Ick Choi
          • Phone Number: +82 010 8821 5297
          • Email: rehab1@yuhs.ac
        • Principal Investigator:
          • Na Young Kim, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with knee osteoarthritis undergoing primary total knee arthroplasty at two hospitals in South Korea.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Improvement
Time Frame: 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).
Preoperative baseline; postoperative 6 weeks, 3 months, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go Test (TUGT) Improvement
Time Frame: Preoperative baseline; postoperative 6 weeks, 3 months, 6 months, and 12 months
Improvement defined as a decrease in TUGT completion time from baseline (binary).
Preoperative baseline; postoperative 6 weeks, 3 months, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Na Young Kim, MD, PhD, Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GBIRB2025-324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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