- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02187653
Intraoperative Monitoring (IOM) Patient Registry (IOM)
Spine Registry Exposure for: Lumbar and Cervical Surgery Utilizing IOM
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Christina R Cook, PhD
- Phone Number: 615-712-9574
- Email: ccook@dc2healthcare.com
Study Contact Backup
- Name: Risa Tyo, PharmD
- Phone Number: 615-712-9574
- Email: rtyo@dc2healthcare.com
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Recruiting
- DC2 Healthcare
-
Contact:
- Christina R Cook, PhD
- Phone Number: 615-712-9574
- Email: ccook@dc2healthcare.com
-
Contact:
- Risa Tyo, PharmD
- Phone Number: 615-712-9574
- Email: rtyo@dc2healthcare.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Lumbar
Patients undergoing lumbar surgery
|
Cervical
Patients undergoing cervical surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline and 24 hours from time of surgery
|
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
|
baseline and 24 hours from time of surgery
|
Complications
Time Frame: At time of surgery
|
At time of surgery
|
|
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
|
baseline and 6 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
|
baseline and 6 weeks
|
Complications
Time Frame: 24 hours after surgery
|
24 hours after surgery
|
|
Complications
Time Frame: 6 weeks after surgery
|
within 6 weeks after surgery but not less than 4 weeks
|
6 weeks after surgery
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DOC 1002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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