Driving After Cervical Spine Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-07-17

Brief Summary

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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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Detailed Description

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Conditions

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Cervical Disc Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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s-ACDFwith STISIM

Single-level anterior cervical discectomy fusion

Group Type EXPERIMENTAL

STISIM driving simulator

Intervention Type 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.

m-ACDF with STISIM

Multi-level anterior cervical discectomy and fusion

Group Type EXPERIMENTAL

STISIM driving simulator

Intervention Type 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.

CDR with STISIM

Cervical disc replacement

Group Type EXPERIMENTAL

STISIM driving simulator

Intervention Type 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.

PCLF with STISIM

Posterior laminectomy and fusion

Group Type EXPERIMENTAL

STISIM driving simulator

Intervention Type 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.

PCD with STISIM

Posterior cervical decompression procedure

Group Type EXPERIMENTAL

STISIM driving simulator

Intervention Type 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.

Control Group with STISIM

Group Type SHAM_COMPARATOR

STISIM driving simulator

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes