NCT02187653

Intraoperative Monitoring (IOM) Patient Registry

Spine Registry Exposure for: Lumbar and Cervical Surgery Utilizing IOM

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: DC2 Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intraoperative Monitoring
• Spinal Diseases

Timeline

• Start date: 2011-09-01
• Primary completion: 2016-12-01
• First posted: 2014-07-11
• Last updated: 2014-07-11

Locations

1 site across 1 country: United States