Clinical trial NCT01232517: NeuroVision® Dynamic Screw Test Study
Official title: A Prospective Evaluation of the Dynamic Function of the NeuroVision® System for the Placement of Lumbar Pedicle Screws
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Spinal Conditions
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2010-11-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Surgical candidates for posterior instrumented lumbar fusion surgery

Brief summary: The purpose of this research study is to gather information about the NeuroVision System (which is FDA cleared for this indication) during the placement of pedicle screws. NeuroVision is a machine that monitors nerve activity during surgery and will alert the surgeon if there are any nerve-related issues during screw placement. The use of nerve monitoring is standard of care at most centers during spine surgery. The standard monitoring for screws placed is performed after the screw is placed, to ensure it is well positioned in the bone (if it is not, the screw may be removed and/or repositioned). The NeuroVision System has a novel feature called "Dynamic Screw Test" that allows for that monitoring to be performed as the screw is placed, rather than after the fact. This study is being done to determine if this real-time monitoring of screw placement provides beneficial additional information to the operating surgeon to prevent misplacement of screws before it happens.


Eligibility criteria: Inclusion Criteria:

1. Male and female patients who are at least 18 years of age.
2. Surgical candidates for posterior instrumented lumbar fusion surgery.
3. Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the study.

Exclusion Criteria:

1. Patients with underlying neurological disease or neurological deficits that are not associated with the condition for which they are seeking surgical intervention.
2. Patients who have had previous instrumented surgery at the involved lumbar level.
3. Participants in any other clinical study involving an investigational device or drug within 30 days of enrollment into the current study.

Primary outcomes:
measure: Sensitivities/specificities of NeuroVision Basic and Dynamic Screw Test monitoring modalities to predict (1) pedicle breach and (2) neural injury
timeFrame: 6 weeks postoperative
Secondary outcomes:
measure: The change in subject self-reported pain ratings (Visual Analog Scales, leg and back pain) from the preoperative period through postoperative follow-up.
timeFrame: 6 weeks postoperative
measure: Intraoperative time (in minutes) taken to place Basic vs Dynamically tested screws.
timeFrame: Intraoperative
measure: Intraoperative fluoroscopy (in minutes) used to place Basic vs Dynamically tested screws.
timeFrame: Intraoperative
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Spokane
country: United States
facility: Northwest Orthopaedic Specialists, PS
state: Washington
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
Study officials:
References: