Driving After Cervical Spine Surgery

NCT02782923 | Completed Results FDA Device

• 1 other identifier: 15-01224
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Disc Disease

Keywords

Cervical Spine Surgery; Simulation

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (6)

s-ACDFwith STISIM

EXPERIMENTAL

Single-level anterior cervical discectomy fusion

Device: STISIM driving simulator

m-ACDF with STISIM

EXPERIMENTAL

Multi-level anterior cervical discectomy and fusion

Device: STISIM driving simulator

CDR with STISIM

EXPERIMENTAL

Cervical disc replacement

Device: STISIM driving simulator

PCLF with STISIM

EXPERIMENTAL

Posterior laminectomy and fusion

Device: STISIM driving simulator

PCD with STISIM

EXPERIMENTAL

Posterior cervical decompression procedure

Device: STISIM driving simulator

Control Group with STISIM

SHAM COMPARATOR

Device: STISIM driving simulator

Interventions

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.

CDR with STISIM; Control Group with STISIM; PCD with STISIM; PCLF with STISIM; m-ACDF with STISIM; s-ACDFwith STISIM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Results Point of Contact

• Title: Yong H. Kim, MD
• Organization: NYU Langone Madison Avenue Orthopaedics

Yong.Kim@nyulangone.org

212-427-3986

Study Officials

• Yong Kim, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: May 25, 2016
• Study Start: December 1, 2016
• Primary Completion: July 17, 2018
• Study Completion: July 17, 2018
• Last Updated: April 30, 2020
• Results First Posted: April 30, 2020

Record last verified: 2020-04

Locations

US (1)