RecruitingNot Applicable

Prediction of Postoperative Outcomes After TKA Using Instrumented Insoles and DNN

South Korea200 participantsStarted 2021-06-01

Plain-language 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.

Who can participate

Age range19 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Western Ontario and McMaster Universities Arthritis Index (WOMAC) Improvement

Timeframe: Preoperative baseline; postoperative 6 weeks, 3 months, 6 months, and 12 months

Trial details

NCT IDNCT07367789

SponsorYonsei University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Na Young Kim, MD, PhD

+82 010 9127 4482 kny8452@yuhs.ac

View on ClinicalTrials.gov More Knee Osteoarthritis trials