Spinal Deformity Intraoperative Monitoring.
Completed · Not applicable
Conditions studied: Spinal Deformity
In brief
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.
Key facts
- Study ID
- NCT03880292
- Run by
- AO Foundation, AO Spine
- People needed
- 569
- Starts
- 2019-05-15
- Expected to finish
- 2022-11-01
- Last updated by the study team
- 2022-11-21
Who can join
Age: 10 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- UC San Franciisco — San Francisco, California, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Columbia University Medical Center — New York, New York, United States
- Duke University Medical Center — Durham, North Carolina, United States
- University of Virginia — Charlottesville, Virginia, United States
- Royal North Shore Hospital — Saint Leonards, Australia
- Hospital Infantil Joana de Gusmão — Florianópolis, Brazil
- Hospital das clinicas de São Paulo e AACD — São Paulo, Brazil
- Shriners Hospital for Children — Montreal, Canada
- Montreal General Hospital — Montreal, Canada
- Toronto Western Hospital — Toronto, Canada
- Nanjing Drum Tower Hospital — Nanjing, China
- Queen Mary Hospital — Hong Kong, Hong Kong
- Mallika Spine Centre — Guntur, India
- Kothari Medical Centre — Kolkata, India
- Tel Aviv Medical Center - Dana Children's Hospital — Tel Aviv, Israel
- Hamamatsu University School of Medicine — Hamamatsu, Japan
- University Medical Center St. Radboud — Nijmegen, Netherlands
- Ghurki Trust Teaching Hospital — Lahore, Pakistan
- Hospital Vall d'Helbron — Barcelona, Spain
- Acibadem Maslak Hospital — Istanbul, Turkey (Türkiye)
- Guys Hospital — London, United Kingdom
- Salford Royal Hospital — Manchester, United Kingdom
- Nottingham Queens Medical Centre — Nottingham, United Kingdom
Full record on ClinicalTrials.gov
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