Cervical Disc Disease, Cervical Disc Herniation, Cervical Myelopathy, Cervical Radiculopathy, Cervical Spine Disease, Cervical Spondylosis, Cervical Stenosis
Conditions
Keywords
Spine surgery
Brief summary
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).
Detailed description
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.
Interventions
None listed
Sponsors
NuVasive
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. Patients who are ≥18 years of age at the time of consent 2. 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: 1. degenerative disc disease, as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies 2. trauma (including fractures) 3. tumors involving the cervical spine 4. cervical spinal deformity (kyphosis, lordosis, or scoliosis) 5. failed previous cervical fusion(s) (e.g., pseudoarthrosis) 6. cervical spondylolisthesis 7. cervical spinal stenosis 3. Able to undergo surgery based on physical exam, medical history, and surgeon judgment 4. Understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study
Exclusion criteria
1. Procedures performed with interbody implants with integrated vertebral body screw(s) 2. Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested) 3. Use of bone growth stimulators postoperatively 4. Active smoking within 6 weeks of surgery 5. Patient has known sensitivity to materials implanted 6. Systemic or local infection (latent or active) or signs of local inflammation 7. Patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment 8. Pregnant, or plans to become pregnant 9. Patient is a prisoner 10. Patient is participating in another clinical study that would confound study data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications NuVasive ACP System | 24 months | Rate of complications (i.e., safety) attributable to use of the NuVasive ACP System |
| Radiographic Success | 24 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcome Success | 24 months | 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) |
| Rate of Postoperative Dysphagia | 24 months | Rate of postoperative dysphagia as measured by the Eating Assessment Tool (EAT-10) |
| Rate of complications attributable to the use of NuVasive instruments, implants, or technologies | 24 months | Rate of complications attributable to the use of NuVasive instruments, implants, or technologies |
Countries
United States
Outcome results
None listed