Driving After Cervical Spine Surgery
Completed · Not applicable
Conditions studied: Cervical Disc Disease
In brief
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.
Key facts
- Study ID
- NCT02782923
- Run by
- NYU Langone Health
- People needed
- 19
- Starts
- 2016-12-01
- Expected to finish
- 2018-07-17
- Last updated by the study team
- 2020-04-30
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- New York University School of Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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