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| Name | Class |
|---|---|
| National Neurosurgical and Orthopedic Optimum Care Continuum (NOC2) Foundation | UNKNOWN |
| National Research Independent Operations Management | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumbar | Patients undergoing lumbar surgery | ||
| Cervical | Patients undergoing cervical surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Complications | At time of surgery | |
| 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 |
| 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 |
| Complications | 24 hours after surgery | |
| Complications | within 6 weeks after surgery but not less than 4 weeks | 6 weeks after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing cervical or lumbar surgery in which intraoperative monitoring has been utilized.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina R Cook, PhD | Contact | 615-712-9574 | ccook@dc2healthcare.com | |
| Risa Tyo, PharmD | Contact | 615-712-9574 | rtyo@dc2healthcare.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DC2 Healthcare | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Label | URL |
|---|---|
| DC2 Healthcare | View source |
| NRIOM | View source |
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| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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