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NCT Number: NCT07367789

Prediction of Postoperative Outcomes After TKA Using Instrumented Insoles and DNN

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases Total Knee Arthroplasty

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Na Young Kim, MD, PhD

CONTACT

[email protected]

+82 010 9127 4482

Seung Ick Choi

CONTACT

[email protected]

+82 010 8821 5297

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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