Intraoperative Monitoring (IOM) Patient Registry

Spinal Diseases Clinical Trial

— IOM  

Official title:

Spine Registry Exposure for: Lumbar and Cervical Surgery Utilizing IOM

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02187653
• Other study ID #: DOC 1002
• Status: Recruiting
• Phase: N/A
• First received: July 7, 2014
• Last updated: July 9, 2014
• Start date: September 2011

Study information

• Verified date: July 2014
• Source: DC2 Healthcare
• Contact: Christina R Cook, PhD
• Phone: 615-712-9574
• Email: ccook[@]dc2healthcare.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intraoperative Monitoring
• Spinal Diseases

Locations

Country	Name	City	State
United States	DC2 Healthcare	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
DC2 Healthcare	National Neurosurgical and Orthopedic Optimum Care Continuum (NOC2) Foundation, National Research Independent Operations Management

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Neurological Assessment at 24 hours	Motor, Reflex, and Sensory testing will be assessed for change from baseline and 24 hours after surgery	baseline and 24 hours from time of surgery	No
Primary	Change in Pain Intensity from Baseline at 24 hours	Pain intensity will be measured by Visual Analogue Scale (VAS) for change from baseline and 24 hours after surgery	baseline and 24 hours from time of surgery	No
Primary	Complications		At time of surgery	Yes
Primary	Change from baseline in Neurological Assessment at 6 weeks	Motor, Reflex, and Sensory testing will be assessed for change from baseline, within 6 weeks but not less than 4 weeks	baseline and 6 weeks	No
Primary	Change in Pain Intensity from Baseline at 6 weeks	Pain intensity will be measured by Visual Analogue Scale (VAS) within 6 weeks but not less than 4 weeks	baseline and 6 weeks	No
Primary	Complications		24 hours after surgery	Yes
Primary	Complications	within 6 weeks after surgery but not less than 4 weeks	6 weeks after surgery	Yes

External Links

•   DC2 Healthcare
•   NOC2 Healthcare
•   NRIOM