NCT07367789 Prediction of Postoperative Outcomes After TKA Using Instrumented Insoles and DNN
| NCT ID | NCT07367789 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yonsei University |
| Condition | Knee Osteoarthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2021-06-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Na Young Kim, MD, PhD
PRINCIPAL INVESTIGATOR
Severance Hospital
Frequently Asked Questions
Who can join the NCT07367789 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07367789 currently recruiting?
Yes, NCT07367789 is actively recruiting participants. Contact the research team at kny8452@yuhs.ac for enrollment information.
Where is the NCT07367789 trial being conducted?
This trial is being conducted at Yongin-si, South Korea.
Who is sponsoring the NCT07367789 clinical trial?
NCT07367789 is sponsored by Yonsei University. The principal investigator is Na Young Kim, MD, PhD at Severance Hospital. The trial plans to enroll 200 participants.