Intraoperative Monitoring (IOM) Patient Registry

DC2 Healthcare

Status: Unknown

Conditions: Intraoperative Monitoring; Spinal Diseases

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02187653

DOC 1002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• There are no specific exclusion criteria

Trial design

10,000 participants in 2 patient groups

Lumbar

Description:

Patients undergoing lumbar surgery

Cervical

Description:

Patients undergoing cervical surgery