Safety and Performance of the SpineVision Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease in Skeletally Mature Patients - HEXANIUM ACIF Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 148
- 试验地点
- 6
- 主要终点
- Incidence of serious adverse device and/or procedure related events
研究概览
简要总结
The goal of this observational study is to confirm the safety and efficacy of the Hexanium ACIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal disk breaks down) at the cervical spine level (C3-C7).
Part of their standard of care, participants will be questioned on their neck and arm pains, their disability and if they have encountered any adverse effects since the Hexanium ACIF system implant surgery. Those data will be collected up to twenty four (24) months after the Hexanium ACIF system implant surgery.
详细描述
The Hexanium ACIF study is a multicentric, non-randomized, ambispective, post market clinical follow-up study. This means that either subjects already implanted with the Hexanium ACIF system (retrospective subjects) or subjects planned for treatment with the Hexanium ACIF system (prospective subjects) can be enrolled in hte study.
Standard of care subjects data up to twenty four (24) months post Hexanium ACIF system implant procedure will be collected; key data include neck and arm Visual Analogue Score (VAS), Neck Disability Index (NDI) score, and adverse events.
Data will be collected at Month 2, Month 6, Month 12 and Month 24 post surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patient planned for Hexanium ACIF system implant or patient implanted with Hexanium ACIF system (not prior July 2020)
- •Patient of 18 years old or more
- •Patient has provided signed informed consent, or did not oppose to his/her data collection, per local regulation
排除标准
- •contra-indication
- •Infection, local to the operative site
- •Signs of local inflammation
- •Fever or leukocytosis
- •Morbid obesity
- •Pregnancy
- •Paediatric cases, or patient still having general skeletal growth
- •Spondylolisthesis unable to be reduced to Grade I
- •Suspected or documented allergy or intolerance to metal
- •Any case where the implant components selected for use would be too large or too small to achieve a successful result
- •Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality
- •Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance
- •Prior fusion at the level to be treated
- •Any case not needing a bone graft or fusion
- •Any abnormality present which affects the normal process of bone remodelling including, but not limited to severe osteoporosis involving spine, bone absorption, osteopenia, primary or metastasis tumours involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis
- •Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumours or congenital abnormalities, fracture local to operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count
- •Mental illness
- •Any patient unwilling to cooperate with postoperative instructions
结局指标
主要结局
Incidence of serious adverse device and/or procedure related events
时间窗: Month 24
Rate of serious adverse events related to the study device and / or surgical implant procedure will be analyzed and compared to the state of the art.
Change of the Neck Disability Index (NDI)
时间窗: Month 12
Neck Disability Index (NDI) mean score at Month 12 will be compared to Neck Disability Index (NDI) mean score at baseline. Neck Disability Index (NDI) score varies between 0% and 100%, with highest score as worst outcome.
次要结局
- Incidence of revision surgery at implant site(Month 2, month 6, month 12 and month 24)
- Change of the Neck Disability index (NDI)(Month 2, month 6, month 12 and month 24)
- Fusion success(Month 2, month 6, month 12 and month 24)
- Change of the neck and arm Visual Analogue Score (VAS)(Month 2, month 6, month 12 and month 24)