Driving After Cervical Spine Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Change in Number of Total Collisions (TC)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
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
Secondary Outcomes
No secondary outcomes reported