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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Mr
Nasir
Quaraishi
Nasir.Quraishi@nuh.nhs.uk
Mr
Nasir
Quaraishi
Nasir.Quraishi@nuh.nhs.uk
Deforming dorsopathies
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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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Cohort study;
You can take part if:
You may not be able to take part if:
Preoperative 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
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by AO Foundation and funded by AO Foundation; SCOLIOSIS RESEARCH SOCIETY; .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 41203
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