Driving After Cervical Spine Surgery

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.

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Key information

Conditions

Cervical Disc Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

STISIM driving simulator

Device

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.

Primary outcomes

Change in Number of Total Collisions (TC)

Time frame: 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)

Time frame: 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)

Time frame: 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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: May 25, 2016
Registry last updated: Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed