Spine Registry Exposure for: Lumbar and Cervical Surgery Utilizing IOM
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- DC2 Healthcare
- Enrollment
- 10,000
- Locations
- 1
- Primary Endpoint
- Change from baseline in Neurological Assessment at 6 weeks
Study Overview
Brief Summary
The primary objective of this study is to evaluate the rate of new or worsening neurologic deficits and/or radiculopathy following lumbar or cervical surgery in light of IOM using neurological testing (motor and sensory) in the optimal management of the surgical patient.
Detailed Description
Prospective reports will be collected on approximately 10,000 patients undergoing lumbar or cervical spinal surgery using intraoperative monitoring. Patients will be enrolled in registry after signing informed consent. Data will be collected prior to surgery, during surgery, immediately following surgery and 4 to 6 weeks post surgery. The registry will serve as a database for surgeries using IOM.
Specific outcome measures will be: neurological assessment, length of hospital stay, pain intensity, and complications.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing lumbar or cervical surgery
- •Utilization of IOM
- •Understand and sign informed consent
Exclusion Criteria
- •There are no specific exclusion criteria
Outcomes
Primary Outcomes
Change from baseline in Neurological Assessment at 6 weeks
Time Frame: baseline and 6 weeks
Motor, Reflex, and Sensory testing will be assessed for change from baseline, within 6 weeks but not less than 4 weeks
Change in Pain Intensity from Baseline at 24 hours
Time Frame: baseline and 24 hours from time of surgery
Pain intensity will be measured by Visual Analogue Scale (VAS) for change from baseline and 24 hours after surgery
Change from baseline in Neurological Assessment at 24 hours
Time Frame: baseline and 24 hours from time of surgery
Motor, Reflex, and Sensory testing will be assessed for change from baseline and 24 hours after surgery
Complications
Time Frame: 6 weeks after surgery
within 6 weeks after surgery but not less than 4 weeks
Change in Pain Intensity from Baseline at 6 weeks
Time Frame: baseline and 6 weeks
Pain intensity will be measured by Visual Analogue Scale (VAS) within 6 weeks but not less than 4 weeks
Secondary Outcomes
No secondary outcomes reported