Driving After Cervical Spine Surgery

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 Overview

• Status: Completed
• Conditions: Cervical Disc Disease
• Intervention / Treatment: Device: STISIM driving simulator

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: s-ACDFwith STISIM; Single-level anterior cervical discectomy fusion	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.
Experimental: m-ACDF with STISIM; Multi-level anterior cervical discectomy and fusion	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.
Experimental: CDR with STISIM; Cervical disc replacement	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.
Experimental: PCLF with STISIM; Posterior laminectomy and fusion	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.
Experimental: PCD with STISIM; Posterior cervical decompression procedure	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.
Sham Comparator: Control Group with STISIM	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Yong Kim, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): July 17, 2018
• Study Completion (Actual): July 17, 2018

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: May 23, 2016
• First Posted (Estimate): May 25, 2016

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 17, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Simulation; Cervical Spine Surgery
• Other Study ID Numbers: 15-01224

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No