An Observational Multicenter Consecutive Case Study of Long-Term Safety and Effectiveness Outcomes of a Real-World Population
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Rate of Quantitative Fusion
研究概览
简要总结
The purpose of this observational, multi-center, ambispective, serial case study is to collect real-world patient outcomes that characterize the long-term safety and effectiveness of the SurGenTec ION 3D® Facet Screw System in a cervical spine and a lumbar spine application.
详细描述
The statistical analysis of the data obtained from this study will be performed using a validated statistical software program such as SPSS®. All tests will be performed at the 0.05 significance level, unless otherwise specified. Analysis will be based upon the treated population defined as all subjects that underwent standard of care surgical intervention with the SurGenTec ION 3D Facet Screw System that agreed to participate in this data collection initiative.
Data collected in this study will be documented using summary tables and subject data listings. Continuous variables will be summarized using descriptive statistics, specifically the mean, median, standard deviation, minimum, and maximum, and a 95% confidence interval for the mean based on the t-distribution. Categorical variables will be summarized using frequencies, percentages, and 95% confidence intervals for the true proportions. Resultant of the observational study design, this evaluation is not powered to test a hypothesis. It is designed to yield supplemental long-term information in this real-world population.
The analysis will be stratified by lumbar and cervical patients. Additionally, each cohort will evaluate the following analysis populations:
Enrolled Population: This dataset will include all subjects who were screened and enrolled into the study.
Evaluable Population: This dataset will exclude subjects with ION 3D Facet Screw device improperly placed
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously implanted intra-facet with one ION® Facet Screw placed per joint bilaterally at one or more contiguous levels of the cervical spine (C3-C7), or one or more contiguous levels of the lumbar spine (L3-S1),
- •Must have supplemental fixation at the target level(s),
- •Skeletally mature (minimum age of 21 years but not greater than 80 years),
- •Be willing and able to comply with the study protocol requirements, and
- •Be willing to sign the study-specific Informed Consent Document.
排除标准
- •Implanted with the ION Facet Screw System at a spinal level that includes the thoracic spine (T1-T12),
- •Unilateral fixation with the ION Fact Screw System,
- •Current active or suspected malignancy, or a cancer diagnosis that was ongoing during the patient's treatment and healing period,
- •Significant metabolic bone disease (diagnosis of osteoporosis or osteomalacia),
- •Currently taking medications that are known to potentially interfere with bone healing (e.g. chronic oral/systemic steroids),
- •Pregnant or nursing female, or
- •Incarcerated at the time of the required 12-month evaluation.
研究组 & 干预措施
Cervical
Previously implanted bilaterally intra-facet with the SurGenTec ION 3D Facet Screw System at one or two contiguous levels of the cervical spine (C3-C7)
干预措施: ION 3D Facet Screw System (Device)
Lumbar
Previously implanted bilaterally intra-facet with the SurGenTec ION 3D Facet Screw System at one or two contiguous levels of the lumbar spine (L3-S1)
干预措施: ION 3D Facet Screw System (Device)
结局指标
主要结局
Rate of Quantitative Fusion
时间窗: 12 Months Post-Op
Defined as \<5 degrees of angulation and/or \<3mm translation as measured on dynamic flexion and extension radiographs
Rate of Stability of operative level(s)
时间窗: 12 Months Post-Op
Substantial motion defined as \>5 degrees angulation and/or \>3mm translation as measured on dynamic flexion and extension radiographs.
Rate of Qualitative Fusion
时间窗: 12 Months Post-Op
Bridging bone present external to the ION 3D facet screw device as observed on CT scan.
Incidence of Serious Adverse Events
时间窗: 12 Months Post-Op
Freedom from ION 3D facet screw device-related serious adverse events as adjudicate by an independent reviewer.
Incidence of Secondary Surgical Events
时间窗: 12 Months Post-Op
Secondary surgical events at the operative level(s) from intraoperative through ≥12-month evaluation timepoint.
次要结局
未报告次要终点