Cervical Disc DiseaseNCT02782923
Driving After Cervical Spine Surgery
A study testing STISIM driving simulator in people with Cervical Disc Disease, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Disc Disease
- What is being tested?
- STISIM driving simulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 17 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
- Conditions
- Cervical Disc Disease
- Being tested
- STISIM driving simulator
- Keywords
- Cervical Spine Surgery, Simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STISIM driving simulatorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| s-ACDFwith STISIM | Experimental | Single-level anterior cervical discectomy fusion Receives: Device: STISIM driving simulator |
| m-ACDF with STISIM | Experimental | Multi-level anterior cervical discectomy and fusion Receives: Device: STISIM driving simulator |
| CDR with STISIM | Experimental | Cervical disc replacement Receives: Device: STISIM driving simulator |
| PCLF with STISIM | Experimental | Posterior laminectomy and fusion Receives: Device: STISIM driving simulator |
| PCD with STISIM | Experimental | Posterior cervical decompression procedure Receives: Device: STISIM driving simulator |
| Control Group with STISIM | Sham comparator | Not described Receives: Device: STISIM driving simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Total Collisions (TC)
Change from Baseline in Overall collisions (BL-3mo). Includes both "off-road" and "on-road" collisions.
Measured: 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.
Measured: 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
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startDec 2016
- Primary completion17 Jul 2018
- Study completion17 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical Disc DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong Kim, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782923
- Sponsor's protocol ID
- 15-01224
- Status last verified
- Apr 2020
- First submitted
- 23 May 2016
- Last updated
- 30 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving After Cervical Spine Surgery
- ClinicalTrials.gov ID
- NCT02782923
- Acronym / sponsor ID
- 15-01224
- Conditions
- Cervical Disc Disease
- Keywords
- Cervical Spine Surgery, Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 17 Jul 2018 (actual)
- First posted
- 25 May 2016 (estimated)
- Results
- Posted 30 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| s-ACDFwith STISIM | Experimental | Device: STISIM driving simulatorSingle-level anterior cervical discectomy fusion |
| m-ACDF with STISIM | Experimental | Device: STISIM driving simulatorMulti-level anterior cervical discectomy and fusion |
| CDR with STISIM | Experimental | Device: STISIM driving simulatorCervical disc replacement |
| PCLF with STISIM | Experimental | Device: STISIM driving simulatorPosterior laminectomy and fusion |
| PCD with STISIM | Experimental | Device: STISIM driving simulatorPosterior cervical decompression procedure |
| Control Group with STISIM | Sham comparator | Device: STISIM driving simulator |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STISIM driving simulatorThis 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. | Device | CDR with STISIM, Control Group with STISIM, PCD with STISIM, PCLF with STISIM, m-ACDF with STISIM, s-ACDFwith STISIM |
Primary outcome
Change in Number of Total Collisions (TC)
Time frame: 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)
Time frame: 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)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cervical Disc Disease
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Not yet recruiting
Effects of Orofacial Myofunctional Therapy and Cervical Stabilization Exercises in Patients With Axis-i Group Iia Temporomandibular Dysfunction
Temporo-mandibular Dysfunction, Disc Displacement
Active, not recruiting
Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels
Cervical Disc Herniation, Cervical Disc Degeneration
RecruitingObservational study
Gelified Radiopaque Ethanol (Absolute Gel) in Cervical Disc Herniation: an Observational Study in Routine Clinical Practice (GENESIS)
Cervical Disc Herniation, Intervertebral Disc Displacement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Kim, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STISIM driving simulator in people with Cervical Disc Disease, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Number of Total Collisions (TC) (time frame: Baseline, 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.