PROSPECTIVE MULTICENTRIC CLINICAL STUDY TO ASSESS SAFETY OF A CORTICAL BONE TRAJECTORY SCREW INSERTION TECHNIQUE WITH THE USE OF PATIENT SPECIFIC DRILL GUIDES
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Bone fusion
研究概览
简要总结
The use of patient specific guides with proper preoperative planning, following a cortical bone trajectory technique, should guarantee a successful surgery and benefit of less invasive technique.
This study intends to measure the safety and efficacity of MySpine MC patient-specific guide system, when used according to its general indication of use and following the surgical technique suggested by the manufacturer
详细描述
Adult patients affected by degenerative disc disease, meeting all inclusion/exclusion criteria, will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit. They will be provided with an information letter and, in case of acceptance to participate to the study, asked to sign a consent form.
After enrolment, each patient will be monitored for 13 months. Data concerning demography, preoperative clinical conditions, surgical details including device implanted and complications occurred, postoperative clinical and/or radiological assessments (as per standard routine at 5 weeks, 3, 7 and 13 months) will be prospectively collected. The level of bone fusion will be evaluated with a postoperative CT scan at 7 ±2 months follow-up
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 surgical treatment one/two levels with posterior approach to screw fixation
- •those who need a surgical procedure of lumbar spine stabilization according to Medacta device instruction for use from level L2 to level S1
- •those who signed consent form to participate to the study
- •Normal healthy patients or with mild systematic disease identified as patients with ASA score 1 or 2
- •Patients with BMI ≤ 35 kg/m2
- •non responsive or unsufficient resposive to non -invasive treatment such as analgesics
排除标准
- •Patients affected by lytic lystesis and degenerative lystesis with grade≥2 will be excluded
- •Patients <18 years
- •Patient who is pregnant or intends to become pregnant during the study
- •Known substance or alcohol abuse
结局指标
主要结局
Bone fusion
时间窗: 6 months
Percentage of subjects get bone fusion at index level will be calculated
次要结局
- Pain perception(preop, 5 weeks, 3months, 6 months, 12 months)
- Functional status(preop, 5 weeks, 3months, 6 months, 12 months)
- Safety device(preop, 5 weeks, 3months, 6 months, 12 months)
- Quality of life(preop, 5 weeks, 3months, 6 months, 12 months)