Trial Outcomes & Findings for Driving After Cervical Spine Surgery (NCT NCT02782923)

NCT ID: NCT02782923

Last Updated: 2020-04-30

Results Overview

Change from Baseline in Overall collisions (BL-3mo). Includes both "off-road" and "on-road" collisions.

Recruitment status

COMPLETED

Study phase

Target enrollment

19 participants

Primary outcome timeframe

Baseline, 3 months

Results posted on

2020-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	Cervical Surgical Patients Participants who have undergone cervical spine surgery
Overall Study STARTED	19
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Cervical Surgical Patients Participants who have undergone cervical spine surgery
Overall Study Lost to Follow-up	15

Baseline Characteristics

Driving After Cervical Spine Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cervical Surgical Patients n=17 Participants Participants who have undergone cervical spine surgery
Age, Continuous	47 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months

Change from Baseline in Overall collisions (BL-3mo). Includes both "off-road" and "on-road" collisions.

Outcome measures

Outcome measures
Measure	Cervical Surgical Patients n=4 Participants Participants who have undergone cervical spine surgery
Change in Number of Total Collisions (TC)	2 collisions/crashes Interval 0.0 to 4.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cervical Surgical Patients n=4 Participants Participants who have undergone cervical spine surgery
Change in Number of Centerline Crossings (CC)	1.5 centerline crossings Interval 0.0 to 2.0

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Cervical Surgical Patients n=4 Participants Participants who have undergone cervical spine surgery
Change in Number of Off-road Excursions (ORE)	0 off-road excursions Interval 0.0 to 0.0

Adverse Events

Cervical Surgical Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yong H. Kim, MD

NYU Langone Madison Avenue Orthopaedics

Phone: 212-427-3986

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place