NCT02782923

Driving After Cervical Spine Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Cervical Disc Disease

Interventions

Type	Name	Description
DEVICE	STISIM driving simulator	This simulator is complete with computerized driving scenarios and driving hardware, has been validated in numerous studies and allows for a more comprehensive investigation of driving performance. The simulated course recreates standard turns, traffic intersections, pedestrian crosswalks, lane changes and several hazardous conditions routinely encountered during driving situations.

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-07-17
• Completion: 2018-07-17
• First posted: 2016-05-25
• Last updated: 2020-04-30
• Results posted: 2020-04-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study