Cervical Disc Disease
Conditions
Keywords
Cervical Spine Surgery, Simulation
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.
Interventions
DEVICESTISIM 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.
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cervical Surgical Patients Participants who have undergone cervical spine surgery | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 15 |
Baseline characteristics
| Characteristic | Cervical Surgical Patients |
|---|---|
| Age, Continuous | 47 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 17 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
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.
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cervical Surgical Patients | Change in Number of Centerline Crossings (CC) | 1.5 centerline crossings |
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
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cervical Surgical Patients | Change in Number of Off-road Excursions (ORE) | 0 off-road excursions |
Primary
Change in Number of Total Collisions (TC)
Change from Baseline in Overall collisions (BL-3mo). Includes both off-road and on-road collisions.
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cervical Surgical Patients | Change in Number of Total Collisions (TC) | 2 collisions/crashes |