Prospective Multicentric Clinical Study to Assess Safety of MUST MINI Posterior Cervical System.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Assessment of MUST MINI system safety
研究概览
简要总结
The goal of this study is to assess the MUST MINI system safety in patient who will undergo a posterior cervical spine fusion intervention. Patients will be invited to partecipate during preoperative visit and follow the postoperative visits according to the standard practice.
详细描述
Patient who will undergo a posterior cervical spine fusion intervention, will be invited during preoperative visit to take part to the study.
The study is an observational multicentric study with an enrolment period of 12 months with the aim to assess the safety of MUST MINI system.
All adverse events will be collected for all study duration, classified as device and not device related. Screw failure rate is calculated considering screw loosening, breakage, lost-reduction events.
Standard radiological investigations are previewed at preoperative visit, before discharge and at 6 weeks and 12 months follow-up after surgery visits; the risk of any further exposure to radiation other than it's routine use in a diagnostic manner within the follow-up period can be excluded.
A final visit at 12 months level index fusion will be evaluated clinically as well as radiographically, with a confirmation CT scan as per standard of care. Screw placement accuracy will be evaluated during this visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •those affected by degenerative disc disease needing a posterior surgical instrumented treatment aimed at segmental fusion,
- •those who will undergo posterior fixation due to traumatic lesion or tumor,
- •Patients with BMI ≤ 35 kg/m2,
- •those who signed the consent form to participate to the study.
排除标准
- •Patients <18 years,
- •Patients who are pregnant or intend to become pregnant during the study.
结局指标
主要结局
Assessment of MUST MINI system safety
时间窗: 24 months
collection of adverse event
次要结局
- Clinical outcomes(preop, 6 weeks, 6 months, 12 months)
- Cervical spine functionality(Immediate postop, 6 weeks, 12 months)
- Bone fusion at index level(12 month)