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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| s-ACDFwith STISIM | Experimental | Single-level anterior cervical discectomy fusion |
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| m-ACDF with STISIM | Experimental | Multi-level anterior cervical discectomy and fusion |
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| CDR with STISIM | Experimental | Cervical disc replacement |
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| PCLF with STISIM | Experimental | Posterior laminectomy and fusion |
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| PCD with STISIM | Experimental | Posterior cervical decompression procedure |
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| Control Group with STISIM | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STISIM driving simulator | Device | 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. |
| 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 |
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Inclusion Criteria:
Study Subjects
Inclusion Criteria
Control Subjects:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong Kim, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervical Surgical Patients | Participants who have undergone cervical spine surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervical Surgical Patients | Participants who have undergone cervical spine surgery |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Number of Total Collisions (TC) | Change from Baseline in Overall collisions (BL-3mo). Includes both "off-road" and "on-road" collisions. | Posted | Median | Full Range | collisions/crashes | Baseline, 3 months |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cervical Surgical Patients | Participants who have undergone cervical spine surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yong H. Kim, MD | NYU Langone Madison Avenue Orthopaedics | 212-427-3986 | Yong.Kim@nyulangone.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 11, 2018 | Apr 17, 2020 | Prot_000.pdf |
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|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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. | Posted | Median | Full Range | centerline crossings | Baseline, 3 months |
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| 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 | Posted | Median | Full Range | off-road excursions | Baseline, 3 months |
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| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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