N/A
Completed N=19
Driving After Cervical Spine Surgery
Cervical Disc Disease
Source: ClinicalTrials.gov NCT02782923 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Change in Number of Total Collisions (TC) — 2 collisions/crashes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Number of Total Collisions (TC) |
2 | — |
| PRIMARY Change in Number of Centerline Crossings (CC) |
1.5 | — |
| PRIMARY Change in Number of Off-road Excursions (ORE) |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02782923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.