Screening and Prospective Cohort Study of Risk Factors for Enhanced Recovery After Spinal Fusion Surgery in Advanced Age Patient
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Safety Metrics for Enhanced Recovery After Spinal Fusion Surgery
研究概览
简要总结
To determine the high risk factors affecting accelerated recovery after spinal fusion surgery in advanced age patient.
详细描述
To determine the high risk factors affecting accelerated recovery after spinal fusion surgery in elderly patients: a prospective cohort study
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed and dated by subject or guardian
- •Commit to follow the research procedures and cooperate with the whole process of the study
- •The subjects are 60 years old or older, regardless of gender
- •Patients with degenerative spinal diseases requiring spinal fusion surgery
- •Generally in good physical condition
- •Able to adhere to and cooperate with research interventions, such as oral medication
- •In fertile women, contraception should be used for at least one month prior to screening, and they should commit to use contraception throughout the study period and continue until the specified time after the study
排除标准
- •Acute infection
- •Congenital malformation
- •Abnormal anatomy or skeletal variation
- •Malignant tumor
- •The surgical area was locally infected with symptoms of local inflammation
- •Fever or leukocytosis
- •Morbid obesity
- •Pregnant and nursing women
- •Mental illness
- •Acute joint disease, bone resorption, osteopenia and/or osteoporosis. Osteoporosis is a relative contraindication, as this condition may limit the degree of correction that can be produced, the amount of mechanical fixation, and/or the quality of the bone graft
- •Patients who are unwilling to cooperate with post-operative treatment
- •Any time an implant is performed it interferes with the anatomy or intended physiological function of the patient
结局指标
主要结局
Safety Metrics for Enhanced Recovery After Spinal Fusion Surgery
时间窗: Baseline. 7 days, 3 months, 6 months, 9 months and 12 months after surgery
Blood routine examination, blood biochemistry, coagulation function, imaging examination (X-ray, CT 3D reconstruction). The number of participants for all adverse events, serious adverse events, implant-related adverse events and drug-related serious adverse events, and the adverse events were summarized accordingly. The severity of adverse events will be rated according to NCI-CTCAE version 4.0.
次要结局
未报告次要终点
研究者
Caoyang
Head of orthopedics; Professor
Wuhan Union Hospital, China