Driving After Cervical Spine Surgery

Cervical Disc Disease Clinical Trial

Official title:

Driving After Cervical Spine Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782923
• Other study ID #: 15-01224
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: July 17, 2018

Study information

• Verified date: April 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 17, 2018
• Est. primary completion date: July 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Disc Disease

Intervention

Device:
• STISIM driving simulator
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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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