Spinal Deformity Intraoperative Monitoring.
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| ClinicalTrials.gov Identifier: NCT03880292 |
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Recruitment Status :
Active, not recruiting
First Posted : March 19, 2019
Last Update Posted : June 28, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Spinal Deformity | Procedure: Document intraoperative Maneuvers | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 569 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | SDIM: Spinal Deformity Intraoperative Monitoring. Understanding and Managing Intraoperative Neuromonitoring Changes During Spinal Deformity Surgery: a Prospective Interventional Study |
| Actual Study Start Date : | May 15, 2019 |
| Actual Primary Completion Date : | March 31, 2022 |
| Estimated Study Completion Date : | September 1, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Intraoperative Maneuvers
To document intraoperative maneuvers performed in repsonse to alerts
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Procedure: Document intraoperative Maneuvers
Monitoring procedure during surgery |
- Number of intraoperative neuromontoring alerts [ Time Frame: Intraoperative ]
Number of intraoperative neuromonitoring alert, defined as a major change in neuromonitoring signals:
- SSEP: amplitude loss > 50%
- MEP: amplitude loss > 50% in two of three muscle groups and/or
- EMG: sustained activity for > 10 seconds
- Intraoperative monitoring alert [ Time Frame: Intraoperative ]
Intraoperative monitoring alerts:
• Degree of change in the monitoring signals (SSEP, MEP, EMG)
- Success rate of reversal maneuvers to restore signal above the threshold [ Time Frame: Intraoperative ]
Number and type of maneuver(s) in response to an alert
- number and type of successful maneuvers
- number and type of unsuccessful maneuvers
- Neurological status [ Time Frame: Baseline up to 30 days postoperative ]
Neurological status:
• ASIA Lower extremity motor and sensory score including if a spinal cord syndrome is applicable. A scale from 0 to 5 points in which 0 denotes total paralysis and 5 normal active movement. Sensory will be meassured as either normal, altered or absent.
- Timing of intraoperative monitoring alerts [ Time Frame: Intraoperative ]Timing: Minutes since skin incision and minutes until recovery in MEP and SSEP
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| Ages Eligible for Study: | 10 Years to 80 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age >10 years to <80 years
- Neurologically intact spinal cord (with or without radiculopathy)
- Undergoing primary or revision procedure in the spine
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880292
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| Responsible Party: | AO Foundation, AO Spine |
| ClinicalTrials.gov Identifier: | NCT03880292 |
| Other Study ID Numbers: |
SDIM |
| First Posted: | March 19, 2019 Key Record Dates |
| Last Update Posted: | June 28, 2022 |
| Last Verified: | June 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Congenital Abnormalities |