Strategic Use of Big Data in Spine Surgery - Testing a Digital Prediction of Outcome Tool in Clinical Praxis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 19
- 主要终点
- Global Assessment (GA)
研究概览
简要总结
The goal of this prospective, multicenter clinical trial is to determine if the use of the postoperative outcome prediction model the Dialogue Support tool can alter postoperative patient-reported outcome and satisfaction compared to current practice.
The main questions it aims to answer are:
- Does its use alter patient-reported outcome measured by general assessment regarding leg pain and Satisfaction in lumbar spinal stenosis?
- Does its use alter patient-reported outcome as measured by general assessment regarding arm pain and Satisfaction in cervical rhizopathy?
- How does the Quality of Life in patients - who after assessment by spinal surgeon do not proceed to surgery - compare with patients with the same baseline profile who did undergo surgery?
Eligible participants will be presented with their predicted postoperative outcome generated by the Dialogue Support tool, as an adjunct to the ordinary assessment by a spine surgeon.
Researchers will compare participants with a matched control group from the Swedish Spine Register ("Swespine") to see if the Dialogue Support tool can alter postoperative patient-reported outcome and satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Refered to a participating clinic regarding surgery for lumbar spinal stenosis or cervical radiculopathy
- •18 years of age or older
- •Magnetic Resonance Imaging (MRT) examination within the last 12 months confirming the diagnosis, concurrent with symptoms described by the referring physician
- •Giving informed consent
排除标准
- •Another condition found to be the reason for the symptoms.
- •Not giving informed consent
- •Need for further investigation that prevents inclusion within one month of the doctor visit.
结局指标
主要结局
Global Assessment (GA)
时间窗: One year post surgery
A retrospective single-item question ("How is your back/leg or neck/arm pain today as compared to before the surgery?"), with six response options (not back/leg pain before surgery/completely gone/much improved/slightly improved/unchanged/worse).
次要结局
- Mortality(One year post surgery)
- Oswestry Disability Index (ODI)(One year post surgery)
- Euroqol-5-Dimensions quality of life questionnaire (EQ-5D)(One year post surgery)
- Neck Disability index (NDI)(One year post surgery)
- Numeric Rating Scales for back/neck and leg/arm pain respectively (NRS)(One year post surgery)
研究者
Catharina Parai, MD, PhD
Principal Investigator
Sahlgrenska University Hospital