Driving After Cervical Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in Number of Total Collisions (TC)
研究概览
简要总结
This is a single-center, prospective controlled simulation study designed comparing and evaluating the driving performance of subjects who have had cervical spine surgery and the use of a validated driving simulator. To date, there haven't been evidence-based recommendations to determine a patient's "fitness to drive" in the peri-operative or postoperative state. The objective of this study is to delineate the effect cervical spine procedures have on driving performance in the peri-operative time period. The study will take place at New York University Langone Medical Center - Hospital for Joint Diseases which will include the surgeries. The follow up visits will be at the NYU Center for Musculoskeletal Care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study Subjects
- •Age between 18 and 80 years
- •Indicated for elective cervical spine surgery (including ACDF [single or multilevel], posterior cervical laminectomy and fusion, posterior cervical laminoplasty, posterior cervical foraminotomy, cervical disc replacement) after failing at least 6 weeks of non-operative treatment modalities
- •Valid driving license
- •Regular use of a vehicle
- •Signed consent form
- •Inclusion Criteria
- •Control Subjects:
- •Age between 18 and 80 years
- •No pre-existing or recent injuries to neck, torso, back
- •No neurologic or systemic debilitating conditions
- •Valid driving license
- •Regular use of a vehicle
- •Signed consent form
排除标准
- •Significant visual impairment
- •Significant debilitating neurological condition with loss of function of one or more extremities
- •Recent extremity surgery
- •Recent eye surgery
- •Previous history of motion sickness, vertigo in simulated settings
- •Recent history of chemical or narcotic dependency involved in active litigation related to their spine problem a the time of screening.
- •Involved in workers compensation related to their spine problem at the time of screening
结局指标
主要结局
Change in Number of Total Collisions (TC)
时间窗: Baseline, 3 months
Change from Baseline in Overall collisions (BL-3mo). Includes both "off-road" and "on-road" collisions.
Change in Number of Centerline Crossings (CC)
时间窗: Baseline, 3 months
Change from baseline in the number of unsafe lane changes. Measured by the number of times the patient failed to check blind spots when changing lanes or changed lanes when another "vehicle" was in the patient's blind spot.
Change in Number of Off-road Excursions (ORE)
时间窗: Baseline, 3 months
Number of off-road excursions was measured by the number of times the patient's "vehicle" traversed the lateral road edge and traveled off onto the grass
次要结局
未报告次要终点