Prospective Comparative Monocentric Research Project Study to Compare Cortical Bone Trajectory Screw Insertion Technique With Pedicle Screw Insertion Technique by Use of Patient Specific Drill Guides
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
- Spine surgical patient outcome changing in the time respect the preoperative
研究概览
简要总结
This research project compares the clinical performance of the cortical bone trajectory CBT insertion technique with the current clinical Gold standard, the Pedicle screw insertion technique. Both techniques are performed by aid of MySpine patient-specific guide systems.
详细描述
Adult subjects, among those whose clinical condition makes them eligible for a spinal stabilization and meeting the inclusion/exclusion criteria, will be invited to participate to the research project and ask to sign a consent in order to further use of personal and clinical data collected during standard practice visit.
The primary objective of the research project is to compare clinical outcomes, in terms of assessing the main outcomes of importance to patients with back problems (pain, function, symptom-specific well-being, quality of life, disability), of spine surgery with cortical bone trajectory screw placement technique respect the traditional pedicle screw placement technique. Preoperative data and collected during visit as per standard routine at 6 weeks, 3, 6 and 12 months postop will be recoreded and assessed for the purpose of this research project.
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
- •patients affected by degenerative disc disease, osteochondrosis and grade I spondylolisthesis needing a one/two level surgical treatment with posterior approach and screw fixation
- •those who need a surgical procedure of lumbar spine stabilization from level L1 to level L
- •patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery
- •Healthy patients or patients with mild or severe systemic disease identified as patients with ASA score 1, 2 or
- •Patients with BMI ≤ 35 kg/m2
- •non responsive or insufficient response to conservative treatment.
排除标准
- •Patients presenting contraindications as defined by Medacta instruction for use
- •Patients affected by lytic spondylolisthesis and degenerative spondylolisthesis with grade≥2 will be excluded
- •Patients <18 years
- •Patients who are pregnant or intend to become pregnant during the study
- •Known substance or alcohol abuse
结局指标
主要结局
Spine surgical patient outcome changing in the time respect the preoperative
时间窗: baseline, 6 weeks, 3 months, 6 months, 12 months
Change in Core Outcome Measures Index (COMI) for the assessment of people affected by degenerative lumbar disease in daily practice
次要结局
- Spine Disability index(baseline, 6 weeks, 3 months, 6 months, 12 months)
- Pain perception(baseline, 6 weeks, 3 months, 6 months, 12 months)
- Bone fusion(baseline, 12 months)
- Incidence of adverse event Device-related(baseline, 6 weeks, 3 months, 6 months, 12 months)