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Driving After Cervical Spine Surgery

NYU Langone Health logo

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)

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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