Driving After Cervical Spine Surgery
Status: | Recruiting |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 1/30/2019 |
Start Date: | December 2016 |
End Date: | November 2019 |
Contact: | Alexandra Lee |
Email: | leea08@nyumc.org |
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.
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.
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
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Afshin Razi, MD
New York University School of Medicine NYU School of Medicine has a proud history that...
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