Spinal Deformity Intraoperative Monitoring.

AO Foundation, AO Spine

Status: Completed

Conditions: Spinal Deformity

Treatments: Procedure: Document intraoperative Maneuvers

Study type: Interventional

Funder types: Other

Identifiers

NCT03880292

SDIM

Details and patient eligibility

About

A multicenter, international prospectively collected patient cohort undergoing high-risk spinal cord level surgery or spinal osteotomy procedures will be enrolled to establish the incidence of intraoperative alerts in high-risk spinal cord cases, and explore factors associated with mitigating injury. Baseline, intraoperative, and postoperative characteristics, including demographics, radiological features, lower extremity motor score (LEMS), procedure, anesthetic agents used, and baseline blood pressure will be recorded for either adult patients or pediatric patients.

Full description

A multicenter, international prospectively collected patient cohort undergoing high-risk spinal cord level surgery or spinal osteotomy procedures will be enrolled to establish the incidence of intraoperative alerts in high-risk spinal cord cases, and explore factors associated with mitigating injury. Baseline, intraoperative, and postoperative characteristics, including demographics, radiological features, lower extremity motor score (LEMS), procedure, anesthetic agents used, and baseline blood pressure will be recorded for either adult patients or pediatric patients.

If a major change occurs in the intraoperative neuromonitoring, defined as a loss of amplitude greater than 50% in the MEP or SSEP from baseline or sustained EMG activity, a separate form (Appendix 3, Intraoperative Alert Form) will be completed in real-time by the neuromonitoring technician outlining the timing of the alert, blood pressure at the time, surgical events at the time of the change, intraoperative maneuvers performed to address the change, and resultant outcome of these maneuvers to address the neuromonitoring change. For each alert occurring during the procedure, a separate form will be completed.

Once the patient is awake from anesthesia, the treating surgeon will perform a neurological examination to identify details about the deficit including sidedness, LEMS, sensory deficit, injury to the nerve root, incomplete spinal cord (ie anterior cord, posterior cord, central cord, Brown-Sequard), complete spinal cord injury, conus or cauda equina deficit. The examination is repeated on the day of discharge from hospital, or at day 30, whichever comes first and documented in the corresponding form.

The objective of this study is to identify the incidence of intraoperative alerts in high-risk spinal cord cases, correlate significant neuromonitoring changes to intraoperative events, and identify maneuvers that will restore the neuromonitoring changes to baseline. The information provided by this study will educate spinal surgeons to recognize a spinal cord at risk and to perform intraoperative maneuvers that will decrease the incidence of neurological injuries.

Enrollment: 569 patients

Sex: All

Ages: 10 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age >10 years to <80 years

• Neurologically intact spinal cord (with or without radiculopathy)

• Undergoing primary or revision procedure in the spine

• Anterior and/or posterior surgical approach for any of the following:

  • Correction of spinal deformity with a major Cobb angle of ≥ 80° in the coronal or sagittal plane
  • Correction of high grade spondylolisthesis (Grades 3- 5)
  • Posterior column or 3-column osteotomy

• Requiring multimodal neuromonitoring with EMG, SSEP, and MEP as per standard of care

• Informed consent obtained for patients i.e.:

  • Ability to understand the content of the patient information
  • Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
  • Signed and dated EC/IRB approved written informed consent OR
  • Written consent obtained according to defined and IRB/EC approved procedures for patients who are not able to provide independent written informed consent

Exclusion Criteria: • Neurodegenerative disease

• Upper motor neuron lesion
• Growing rods or growth guidance procedures
• Tether or staple procedures
• Stand-alone cervical deformity correction procedures
• Any not medically managed severe systemic disease
• Recent history of substance abuse (ie recreational drugs, alcohol) that would preclude reliable assessment
• Pregnancy or women planning to conceive within the study period
• Prisoner
• Participation in any other medical device or medicinal product study that could influence the results of the present study

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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569 participants in 1 patient group

Intraoperative Maneuvers

Other group

Description:

To document intraoperative maneuvers performed in repsonse to alerts

Treatment:

Procedure: Document intraoperative Maneuvers