Clinical Trials in the USA / NCT05066711
Enrolling by invitation
Observational
NuVasive® ACP System Study
NCT05066711 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Cervical SpondylosisCervical RadiculopathyCervical MyelopathyCervical Disc DiseaseCervical StenosisCervical Disc HerniationCervical Spine Disease
Study 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).
Eligibility
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
Primary outcome measure(s)
- 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
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Duly Health and Care | Naperville | Illinois | |
| Columbia Orthopedic Group Research | Columbia | Missouri | |
| Atlantic Brain and Spine | Wilmington | North Carolina |
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Other trials for the same condition
A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Cervical Disc Disease at 2 Contiguous Levels
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M6-C Post Approval Study (PAS)
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Effectiveness of AlloWrap® for the Reduction of Inflammation in ACDF Procedures
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05066711 on ClinicalTrials.gov ↗ ← All trials in the USA