Driving After Cervical Spine Surgery

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT02782923
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arms: 6
• Duration (Months): 19.5
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Disc Disease	Device: STISIM driving simulator	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Driving After Cervical Spine Surgery
• Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Jul 17, 2018
• Actual Study Completion Date: Jul 17, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in Number of Total Collisions (TC) [Baseline, 3 months]

   Change from Baseline in Overall collisions (BL-3mo). Includes both "off-road" and "on-road" collisions.

2. Change in Number of Centerline Crossings (CC) [Baseline, 3 months]

   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.

3. Change in Number of Off-road Excursions (ORE) [Baseline, 3 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Jun 11, 2018

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02782923
• Other Study ID Numbers: 15-01224
• First Posted: May 25, 2016
• Last Update Posted: Apr 30, 2020
• Last Verified: Apr 1, 2020

• 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
• Keywords provided by NYU Langone Health: Cervical Spine Surgery; Simulation

Study Results

Participant Flow

Arm/Group Title	Cervical Surgical Patients
Arm/Group Description	Participants who have undergone cervical spine surgery
Period Title: Overall Study
STARTED	19
COMPLETED	4
NOT COMPLETED	15

Baseline Characteristics

Arm/Group Title	Cervical Surgical Patients
Arm/Group Description	Participants who have undergone cervical spine surgery
Overall Participants	17
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	47
Sex: Female, Male (Count of Participants)
Female	8 47.1%
Male	9 52.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 5.9%
Not Hispanic or Latino	16 94.1%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 23.5%
White	11 64.7%
More than one race	0 0%
Unknown or Not Reported	2 11.8%
Region of Enrollment (Count of Participants)
United States	17 100%

Outcome Measures

1. Primary Outcome

Title	Change in Number of Total Collisions (TC)
Description	Change from Baseline in Overall collisions (BL-3mo). Includes both "off-road" and "on-road" collisions.
Time Frame	Baseline, 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cervical Surgical Patients
Arm/Group Description	Participants who have undergone cervical spine surgery
Measure Participants	4
Median (Full Range) [collisions/crashes]	2

2. Primary Outcome

Title	Change in Number of Centerline Crossings (CC)
Description	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.
Time Frame	Baseline, 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cervical Surgical Patients
Arm/Group Description	Participants who have undergone cervical spine surgery
Measure Participants	4
Median (Full Range) [centerline crossings]	1.5

3. Primary Outcome

Title	Change in Number of Off-road Excursions (ORE)
Description	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
Time Frame	Baseline, 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cervical Surgical Patients
Arm/Group Description	Participants who have undergone cervical spine surgery
Measure Participants	4
Median (Full Range) [off-road excursions]	0

Adverse Events

Time Frame	6 months
Arm/Group Title	Cervical Surgical Patients
Arm/Group Description	Participants who have undergone cervical spine surgery
All Cause Mortality
	Cervical Surgical Patients
	Affected / at Risk (%)	# Events
Total	0/17 (0%)
Serious Adverse Events
	Cervical Surgical Patients
	Affected / at Risk (%)	# Events
Total	0/17 (0%)
Other (Not Including Serious) Adverse Events
	Cervical Surgical Patients
	Affected / at Risk (%)	# Events
Total	0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.