Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT03880292
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
80 Years
Study:
NCT03880292
Study Brief:
Protocol Section:
NCT03880292