A Prospective, Multicenter Study Evaluating the Safety and Performance of the NuVasive® ACP System for the Treatment of Patients With Pathologic Conditions of the Cervical Spine
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- Complications NuVasive ACP System
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •degenerative disc disease, as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
- •trauma (including fractures)
- •tumors involving the cervical spine
- •cervical spinal deformity (kyphosis, lordosis, or scoliosis)
- •failed previous cervical fusion(s) (e.g., pseudoarthrosis)
- •cervical spondylolisthesis
- •cervical spinal stenosis
- •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
排除标准
- •Procedures performed with interbody implants with integrated vertebral body screw(s)
- •Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
- •Use of bone growth stimulators postoperatively
- •Active smoking within 6 weeks of surgery
- •Patient has known sensitivity to materials implanted
- •Systemic or local infection (latent or active) or signs of local inflammation
- •Patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment
- •Pregnant, or plans to become pregnant
- •Patient is a prisoner
- •Patient is participating in another clinical study that would confound study data
结局指标
主要结局
Complications NuVasive ACP System
时间窗: 24 months
Rate of complications (i.e., safety) attributable to use of the NuVasive ACP System
Radiographic Success
时间窗: 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
次要结局
- Rate of complications attributable to the use of NuVasive instruments, implants, or technologies(24 months)
- Clinical Outcome Success(24 months)
- Rate of Postoperative Dysphagia(24 months)