Carbofix Pedicle Screw System: Randomized Clinical Trial to Evaluate the Clinical and Radiographic Outcomes of the Use of a Carbon Fiber Device Compared to Titanium Devices in Patients Undergoing Spinal Arthrodesis for Degenerative Spinal Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Fusion rate
研究概览
简要总结
Previous clinical study carried out on cancer patients at IOR Spine Surgery (approved in October 2014). The carbon device is indicated in patients suffering from vertebral tumors who need stabilization and will then carry out radiotherapy, because carbon has a practically zero level of interference with ionizing radiation. Carbon also allows for better visualization of the implants on MRI/CT and X-ray. There are no studies in the literature analyzing the use of carbon fiber devices in lumbar degenerative pathologies.
118 patients suffering from degenerative spinal pathology requiring 1 or 2 levels of lumbar or lumbosacral fusion will be valutated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 suffering from degenerative spinal pathology or spondylolisthesis who require instrumented stabilization on 1-2 levels;
- •Age greater than or equal to 18 years;
- •Ability to understand and sign the informed consent to the study and to follow the required follow-ups.
排除标准
- •Metabolic bone disease.
- •History of Paget's disease or other osteodystrophies, whether acquired or congenital, including renal osteodystrophy, hyperthyroidism, hypothyroidism, Ehlers-Danlos syndrome, osteogenesis imperfecta, achondroplasia.
- •Neoplastic disease.
- •History of mental disorder or current psychiatric treatment.
- •Pregnancy.
- •Immunodeficiency diseases.
- •Infectious bone disease (discitis, osteomyelitis)
- •Treatment with drugs that can interfere with bone metabolism
- •Inability to understand and sign the informed consent to the study and to follow the required follow-up visits.
- •Alcohol and/or drug abuse
- •Metal allergy
- •Participation in other studies on drugs or devices (within 30 days)
研究组 & 干预措施
Traditional
Titanium implant for spinal surgery
干预措施: Titanium (Procedure)
Experimental
CarboFix implant for spinal surgery
干预措施: Carbofix (Procedure)
结局指标
主要结局
Fusion rate
时间窗: through study completion, an average of 1 year
Fusion rate after 12 months as demonstrated by computed tomography scan (CT scan). The CT scan will be evaluated by Brantigan scale.
次要结局
- Visual Analogue Scale(after 6 months)
- EuroQoL-5D(after 6 months)
- Short Form-12(after 6 months)
- Classification system of surgical complications specific for spine(up to 12 months)
- Oswestry Disability Index(after 6 months)