A Post Market Surveillance Validation to Evaluate the Effectiveness of the MaxAn Anterior Cervical Plate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 6
- 主要终点
- Number of Participants With Differing Severity of Adjacent Level Ossification
研究概览
简要总结
This study is being performed to document the outcomes of subjects using our MaxAn Anterior Cervical Plate and assess them for Adjacent level Disease. All subjects will be followed for 2 years.
详细描述
The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the MaxAn® Anterior Cervical Plate System. Dr. Park, et.al conducted a retrospective review and found a positive association between adjacent-level ossification following anterior cervical plate procedures and the plate-to-disc distance. 1 They concluded that when the anterior cervical plates were placed at least 5mm away from the adjacent disc spaces, there was a decrease in the likelihood of moderate-to-severe adjacent-level ossification. The design of the MaxAn Anterior Cervical Plate and accompanying technique allows this type of plate placement; therefore we will be looking at the radiographic outcomes of these subjects and comparing them to the retrospective chart review conducted by Dr. Park using the MaxAn Technique allows you to achieve plate placement of 5mm from the supraadjacent level which will help minimize the risk of adjacent level ossification.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subject is scheduled to undergo a one to three-level primary spinal fusion surgery between the levels of C2-T1 (Cervical 2 to Thoracic 1) using the MaxAn® Anterior Cervical Plate System.
- •Subject has agreed to participate in this study, sign the informed consent and have agreed to return for the 6, 12 and 24 month follow-up visits.
- •Subjects or their representative must be willing and able to give informed consent.
排除标准
- •Subject has spinal infection or inflammation at any level.
- •Subject is morbidly obese, defined as a BMI greater than
- •Subject has a mental illness, alcoholism or drug abuse.
- •Subject has a metal sensitivity/foreign body sensitivity.
- •Subject has inadequate tissue coverage over the operative site.
- •Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, osteopenia and/or osteoporosis.
- •Female subjects who are pregnant or plan to become pregnant in the next 24 months or who are lactating.
- •Subject who does not meet the specific indications for use of the MaxAn® Anterior Cervical Plate System.
- •Subjects participating in another clinical research study.
- •Any previous cervical spinal surgery.
结局指标
主要结局
Number of Participants With Differing Severity of Adjacent Level Ossification
时间窗: 24 Months
Qualitatively assessed by an independent Radiologist using lateral radiographs Grade 0 - None Grade 1 - Mild (if the ossification extended across \<50% of the disc space) Grade 2 - Moderate (if the ossification extended across ≥ 50% of the disc space) Grade 3 - Severe (if there is complete bridging of the adjacent disc space)
次要结局
- Change in Neck Disability Index (NDI)(24 Months)