The primary objective of this study is to evaluate the safety and performance of anterior cervical spine surgery using the NuVasive anterior cervical plate (ACP) System as measured by reported complications, radiographic outcomes, and patient-reported outcomes (PROs).
This study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of the NuVasive ACP System in patients who undergo anterior cervical spine surgery. Consecutive patients at a given site who meet eligibility requirements will be asked to consent to participate in the study. These patients will present with pathologic conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled in the study, subjects will undergo anterior cervical spine surgery using the NuVasive ACP System based on the surgeon's standard of care. At least 75 subjects will be enrolled and will be followed for 24 months after the surgery.
Study Type
OBSERVATIONAL
Enrollment
75
Duly Health and Care
Naperville, Illinois, United States
Columbia Orthopedic Group Research
Columbia, Missouri, United States
Atlantic Brain and Spine
Wilmington, North Carolina, United States
Complications NuVasive ACP System
Rate of complications (i.e., safety) attributable to use of the NuVasive ACP System
Time frame: 24 months
Radiographic Success
Proportion of subjects with radiographic success at: 1. Latest time point available for patients undergoing surgery to treat advanced stage tumors 2. 24 months postoperative for subjects undergoing surgery to treat instabilities, traumatic spinal fractures, failed previous fusions, or degenerative disease
Time frame: 24 months
Clinical Outcome Success
Percentage of subjects meeting minimal clinically important difference (MCID) and/or substantial clinical benefit (SCB) thresholds for each PRO: neck and arm pain (measured by visual analog scale (VAS)), disability (measured by neck disability index (NDI)), and overall physical and mental health (measured by PROMIS-10)
Time frame: 24 months
Rate of Postoperative Dysphagia
Rate of postoperative dysphagia as measured by the Eating Assessment Tool (EAT-10)
Time frame: 24 months
Rate of complications attributable to the use of NuVasive instruments, implants, or technologies
Rate of complications attributable to the use of NuVasive instruments, implants, or technologies
Time frame: 24 months
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