Driving After Cervical Spine Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Driving After Cervical Spine Surgery

Conditions
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Cervical Disc Disease

Intervention / Treatment
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* Device: STISIM driving simulator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: s-ACDFwith STISIM<br>Single-level anterior cervical discectomy fusion | Device: STISIM driving simulator<br>* 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.<br>|
| Experimental: m-ACDF with STISIM<br>Multi-level anterior cervical discectomy and fusion | Device: STISIM driving simulator<br>* 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.<br>|
| Experimental: CDR with STISIM<br>Cervical disc replacement | Device: STISIM driving simulator<br>* 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.<br>|
| Experimental: PCLF with STISIM<br>Posterior laminectomy and fusion | Device: STISIM driving simulator<br>* 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.<br>|
| Experimental: PCD with STISIM<br>Posterior cervical decompression procedure | Device: STISIM driving simulator<br>* 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.<br>|
| Sham Comparator: Control Group with STISIM<br> | Device: STISIM driving simulator<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of Total Collisions (TC) | Change from Baseline in Overall collisions (BL-3mo). Includes both off-road and on-road collisions. | 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. | 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 | Baseline, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Spine Surgery, Simulation