Outpatient Posterior Cervical Decompression, Instrumentation, and Fusion: The First Consecutive 100 Cases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Neurologic Function (Modified JOA Score)
研究概览
简要总结
Observational study regarding outcomes, complications, and patient acceptance for 100 consecutive patients undergoing outpatient posterior cervical decompression, instrumentation and fusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with neurological signs and symptoms related to cervical stenosis, confirmed by MRI, who have failed to improve with appropriate conservative management.
排除标准
- •patients who represent an inordinate risk to undergo general anesthesia in the outpatient setting.
结局指标
主要结局
Neurologic Function (Modified JOA Score)
时间窗: Baseline and 3 months post-operative
Neurologic status will be assessed using the Modified Japanese Orthopaedic Association (mJOA) Score (1-18), with higher scores indicating better neurologic function.
Myelopathy Severity (Nurick Grade)
时间窗: Baseline and 3 months post-operative
Myelopathy severity will be measured using the Nurick Scale (Grades 0-5), with higher grades indicating greater impairment.
Pain Severity (VAS Neck and Arm Pain Scores)
时间窗: Baseline, 3 months post-operative, and final follow-up (average 5 years)
Pain will be assessed using the Visual Analog Scale (VAS) for neck and arm pain (0-10).
Functional Disability (Oswestry Neck Pain Index)
时间窗: Baseline and 3 months post-operative
Functional impairment will be assessed using the Oswestry Neck Pain Index (0-100%).
Surgical Outcome Rating (Odom Criteria)
时间窗: 3 months post-operative and extended follow-up (average 5 years)
Patient-reported surgical outcome will be graded using Odom Criteria (Excellent, Good, Fair, Poor).
次要结局
- Number of Participants With Postoperative Complications or Readmissions(Day of surgery through study completion (average 5 years))
- Number of Participants With Radiographic Evidence of Fusion or Hardware Failure(6 weeks, 3 months, and extended follow-up (average 5 years))