Driving After Cervical Spine Surgery

Not Applicable

Completed

• Conditions: Cervical Disc Disease
• Interventions: Device: STISIM driving simulator

• Registration Number: NCT02782923
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-05-23
• Study First Posted: 2016-05-25
• Study Start: 2016-12
• Primary Completion: 2018-07-17
• Study Completion: 2018-07-17
• Status Verified: 2020-04
• Results First Submitted: 2020-04-17
• Results First Submitted QC: 2020-04-17
• Last Update Submitted: 2020-04-17
• Results First Posted: 2020-04-30
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
s-ACDFwith STISIM	STISIM driving simulator	Single-level anterior cervical discectomy fusion
CDR with STISIM	STISIM driving simulator	Cervical disc replacement
Control Group with STISIM	STISIM driving simulator	-
PCD with STISIM	STISIM driving simulator	Posterior cervical decompression procedure
m-ACDF with STISIM	STISIM driving simulator	Multi-level anterior cervical discectomy and fusion
PCLF with STISIM	STISIM driving simulator	Posterior laminectomy and fusion

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States