Driving After Cervical Spine Surgery

NYU Langone Health19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cervical Disc Disease

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Number of Total Collisions (TC)

Change from Baseline in Overall collisions (BL-3mo). Includes both "off-road" and "on-road" collisions.

Time frame: Baseline, 3 months

Change in Number of Centerline Crossings (CC)

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.

Time frame: Baseline, 3 months

Change in Number of Off-road Excursions (ORE)

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

Time frame: Baseline, 3 months

Driving After Cervical Spine Surgery

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes