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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACP System |
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| Measure | Description | Time Frame |
|---|---|---|
| Complications NuVasive ACP System | Rate of complications (i.e., safety) attributable to use of the NuVasive ACP System | 24 months |
| Radiographic Success | Proportion of subjects with radiographic success at:
| 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 24 months |
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Inclusion Criteria:
Patients who are ≥18 years of age at the time of consent
Have planned anterior cervical (C2 to C7) spine surgery using the NuVasive ACP System in conjunction with a NuVasive interbody implant or vertebral body replacement device (VBR), or a structural bone allograft spacer, for treatment of any of the following conditions:
Able to undergo surgery based on physical exam, medical history, and surgeon judgment
Understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study
Exclusion Criteria:
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The Enrolled Population will include all subjects who meet the criteria for enrollment, specifically, those subjects who:
The Evaluable Populations will include all subjects who:
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Malone, MS | Globus Medical Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duly Health and Care | Naperville | Illinois | 60540 | United States | ||
| Columbia Orthopedic Group Research |
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| ID | Term |
|---|---|
| D055009 | Spondylosis |
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D010523 | Peripheral Nervous System Diseases |
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| Rate of Postoperative Dysphagia | Rate of postoperative dysphagia as measured by the Eating Assessment Tool (EAT-10) | 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 | 24 months |
| Columbia |
| Missouri |
| 65201 |
| United States |
| Atlantic Brain and Spine | Wilmington | North Carolina | 28401 | United States |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |