Driving After Cervical Spine Surgery

NYU Langone Health

Status: Completed

Conditions: Cervical Disc Disease

Treatments: Device: STISIM driving simulator

Study type: Interventional

Funder types: Other

Identifiers

NCT02782923

15-01224

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 6 patient groups

s-ACDFwith STISIM

Experimental group

Description:

Single-level anterior cervical discectomy fusion

Treatment:

Device: STISIM driving simulator

m-ACDF with STISIM

Experimental group

Description:

Multi-level anterior cervical discectomy and fusion

Treatment:

Device: STISIM driving simulator

CDR with STISIM

Experimental group

Description:

Cervical disc replacement

Treatment:

Device: STISIM driving simulator

PCLF with STISIM

Experimental group

Description:

Posterior laminectomy and fusion

Treatment:

Device: STISIM driving simulator

PCD with STISIM

Experimental group

Description:

Posterior cervical decompression procedure

Treatment:

Device: STISIM driving simulator

Control Group with STISIM

Sham Comparator group

Treatment:

Device: STISIM driving simulator