Prediction of Patient-reported Outcome Measure and Performance-based Measure After Total Knee Arthroplasty Using Instrumented Insoles and Deep Neural Networks
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) Improvement
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Instrumented Insole Gait Assessment (Other)
结局指标
主要结局
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Improvement
时间窗: 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).
次要结局
- Timed Up and Go Test (TUGT) Improvement(Preoperative baseline; postoperative 6 weeks, 3 months, 6 months, and 12 months)