Prediction of Postoperative Outcomes After TKA Using Instrumented Insoles and DNN
Recruiting · NCT07367789 · Observational (researchers observe without assigning treatment) · Lead sponsor: Yonsei University
View the official record on ClinicalTrials.gov →Interventions studied
Instrumented Insole Gait Assessment
What this trial is 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.
Who can take part
Age range
19 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Yongin Severance Hospital - Yongin-si, Gyeonggi-do, South Korea