Intraoperative Monitoring (IOM) Patient Registry

• Conditions: Intraoperative Monitoring; Spinal Diseases

• Registration Number: NCT02187653
• Lead Sponsor: DC2 Healthcare

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 Timeline

• Study Start: 2011-09
• Status Verified: 2014-07
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-09
• Last Update Submitted: 2014-07-09
• Study First Posted: 2014-07-11
• Last Update Posted: 2014-07-11
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• Patients undergoing lumbar or cervical surgery
• Utilization of IOM
• Understand and sign informed consent

Exclusion Criteria

• There are no specific exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in Neurological Assessment at 6 weeks	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	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	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	6 weeks after surgery	within 6 weeks after surgery but not less than 4 weeks
Change in Pain Intensity from Baseline at 6 weeks	baseline and 6 weeks	Pain intensity will be measured by Visual Analogue Scale (VAS) within 6 weeks but not less than 4 weeks

Trial Locations

Locations (1)

DC2 Healthcare; 🇺🇸 Nashville, Tennessee, United States