Safety and Performance of the SpineVision Posterior Fixation Systems Lumis®, Plus® and Ulis® in Thoracolumbar Spinal Degenerative Pathologies or Degenerative Disc Disease (DDD) Associated Pathologies Treatment - Fixed D3 Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 3
- 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 performance of the three (3) Spinevision posterior fixations systems Lumis®, Plus® and Ulis® , in the treatment of patient suffering from thoracolumbar spinal degenerative pathologies, or degenerative disc disease (disease that occurs when the spinal disk break down) associated pathologies.
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 Spinevision posterior fixation system implant surgery. Those data will be collected up to twenty four (24) months after the Spinevision posterior fixation system implant surgery.
详细描述
The Fixed D3 study is a multicentric, non-randomized, ambispective, post market clinical follow-up study. This means that either subjects already implanted with one (1) of the Spinevision posterior fixations systems (Lumis, Plus or Ulis) - retrospective subjects - or subjects planned for treatment with one of the Spinevision posterior fixation system (prospective subjects) can be enrolled in the study.
Standard of care data up to twenty four (24) months post Spinevision posterior fixation system implant procedure will be collected; key data include back and leg Visual Analogue Score (VAS) pain, Oswestry Disability Index (ODI) score, and adverse events.
Data will be collected at pre-operative, per-operative, and post-operative Month 2, Month 6, Month 12 and Month 24.
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 implanted with Lumis®, Plus® or Ulis® posterior fixation system
- •Patient of 18 years old and 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
- •trauma (i.e., fracture or dislocation)
- •Known or suspected allergy or intolerance to the implanted material, mainly to metal (e.g., cobalt, chromium, nickel, etc.)
- •Any other medical or surgical condition likely to compromise the success of instrumented surgery, such as the presence of a malignant tumor or serious congenital abnormalities, raised erythrocyte sedimentation rate not explained by other diseases, high white blood cell count or a tendency to low white blood cell count
- •All cases not described in the indications
- •Localized infection of the operative site
- •All patients with insufficient tissue cover of the operative site
- •Local signs of inflammation
- •Fever or leukocytosis
- •Pathological obesity
- •Pregnancy
- •Mental illness
- •Rapidly evolving joint diseases, bone absorption, osteopenia and/or osteoporosis. Osteoporosis is a relative contraindication, as this medical condition can limit the expected correction gain and stability of mechanical fixation
- •All cases not requiring bone graft or bone fusion
- •When pedicular screws are used, absence or malformation of pedicles
- •All cases requiring a combination of different metals
- •All patients not agreeing to comply with post-operative instructions
结局指标
主要结局
Change of the Oswestry Disability Index (ODI)
时间窗: Month 12
Oswestry Disability Index (ODI) mean score at Month 12 will be compared to the ODI mean score at baseline.
Incidence of serious and non-serious device- and/or procedure-related adverse events
时间窗: Month 24
Rate of the serious and non-serious device- and/or procedure-related adverse events will be analyzed and compared to the state of the art.
次要结局
- Change of the back and leg Visual Analogue Score (VAS)(Month 2, month 6, month 12 and month 24)
- Change of the Oswestry Disability Index (ODI)(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)
- Fusion success(Month 2, month 6, month 12 and month 24)