Brain Network-based Precision Medicine to Predict Dissatisfaction Following Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Preoperative Resting-State fMRI Brain connectivity as a Predictor of Patient operative Satisfaction after Total Knee Arthroplasty measured by Patient-Reported Outcomes Measurement Information System (PROMIS )
研究概览
简要总结
Knee replacement surgery is a common and effective treatment for pain and mobility loss, yet up to 1 in 5 patients remain dissatisfied after surgery due to ongoing pain or difficulty with daily activities. Currently, clinicians cannot reliably predict which patients will experience these challenges.
This study uses MRI scan of the brain to investigate whether specific patterns of brain activity can predict patient satisfaction after total knee arthroplasty (TKA). By comparing brain networks before surgery and afterward, and linking these changes to patient-reported pain and function, we aim to identify brain-based markers that can help predict outcomes, to improve satisfaction after knee replacement surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 18 years or older
- •Primary TKA
- •Diagnosis of osteoarthritis, inflammatory arthritis, or osteonecrosis
排除标准
- •Inability or refusal to sign informed consent form
- •Non-English or French speaking, and no licensed translator, family member or substitute decision maker available
- •History of major neurological disorders (e.g traumatic brain injury, epilepsy, multiple sclerosis
- •Cognitive impairment or dementia
- •Revision and/or Bilateral TKA
- •Chronic Opioid use
研究组 & 干预措施
fMRI Brain Scan
干预措施: fMRI Brain Scan (Procedure)
结局指标
主要结局
Preoperative Resting-State fMRI Brain connectivity as a Predictor of Patient operative Satisfaction after Total Knee Arthroplasty measured by Patient-Reported Outcomes Measurement Information System (PROMIS )
时间窗: Preoperative (Baseline)
Using 50 pre-operative brain networks derived from advanced brain imaging will be assessed as predictors of postoperative patient satisfaction. Patient satisfaction measured by PROMIS questionnaire Preoperative resting-state fMRI brain connectivity will be assessed as a predictor of postoperative patient satisfaction measured using PROMIS questionnaires, which assess pain and function.
Preoperative Resting-State fMRI Brain connectivity as a Predictor of Patient operative Satisfaction after Total Knee Arthroplasty measured by Oxford Knee Score (OKS)
时间窗: Time Frame: Preoperative (Baseline)
Preoperative resting-state fMRI brain connectivity will be assessed as a predictor of postoperative patient satisfaction measured using the Oxford Knee Score, which assesses knee function and pain.
次要结局
- Longitudinal Change in Brain Network Connectivity from Preoperative to 12 months after total knee arthroplasty(Pre-operative to 12-months Post-operative)
- Identification of Key Brain Network Nodes Associated with Postoperative Dissatisfaction after total knee arthroplasty(12 months postoperative)