Safety and Performance of the Hexanium TLIF System in the Treatment of Skeletally Mature Patients Suffering From Degenerative Disc Disease - Hexanium TLIF Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 187
- 试验地点
- 6
- 主要终点
- Change of the Oswestry Disability Index (ODI)
研究概览
简要总结
The goal of this observational study is to confirm the safety and efficacy of the Hexanium TLIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal disk break down).
Part of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Hexanium TLIF system implant surgery. Those data will be collected up to twenty four (24) months after the Hexanium TLIF system implant surgery.
详细描述
The Hexanium TLIF study is a multicentric, international, ambispective, post market clinical follow-up study. This means that either subjects already implanted with the Hexanium TLIF system (retrospective subjects) or subjects planned for treatment with the Hexanium TLIF (prospective subjects) can be enrolled in the study.
Standard of care subjects data up to twenty four (24) months post Hexanium TLIF system implant procedure will be collected; key data include back and leg Visual Analogue Score (VAS), Oswestry Disability Index (ODI) 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 TLIF system implant or patient implant with Hexanium TLIF system (not prior to July 2021)
- •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
- •Signed 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 post-operative instructions
结局指标
主要结局
Change of the Oswestry Disability Index (ODI)
时间窗: Month 12
ODI mean score at Month 12 will be compared to the ODI mean score at baseline.
Incidence of serious adverse device and/or procedure related events
时间窗: Month 24
Rate of the serious adverse events related to the study device and / or surgical implant procedure will be analyzed and compared to the state of the art.
次要结局
- Change of the Oswestry Disability Index (ODI)(Month 2, month 6, and month 24)
- Change of the back and leg Visual Analogue Score (VAS)(Month 2, month 6, month 12 and month 24)
- Fusion success(Month 2, month 6, month 12 and month 24)
- Incidence of revision surgery at implant site(Month 2, month 6, month 12 and month 24)