DRKS00032922尚未招募不适用
Sponsor-initiated, retro- and prospective, monocentric, non-interventional clinical observational study (AWB) to evaluate the ROCCIA MultiLIF® (as ALIF) cage system and the ROCCIA® ALIF cage system in spine surgery use as intended - PMCF ROCCIA MultiLIF ROCCIA ALIF
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •?The surgical indication must be one or a combination of the following
- •oIndications according to IFU
- •- Degenerative disc diseases
- •- Deformities
- •- Segmental dysfunctions of the lumbar or thoracolumbar spine
- •- Spondylolistheses
- •- Segmental instabilities
- •- Stenoses
- •?Mono-, bi- und multisegmental instrumentation
- •?Age: = 18 years
- •?Surgical technique: ROCCIA MultiLIF® ALIF cage system or ROCCIA®
- •ALIF cage system used with additional stabilization
- •?Patients for prospective part of the PMCF study must provide written
- •informed consent prior to any action related to the PMCF study
排除标准
- •Relative and absolute contraindications according to IFU
- •Absolute contraindications
- •- Expected or documented allergy or intolerance to the materials (e.g. titanium).
- •- Any case in which the chosen implants would be too large or too small to achieve a successful result.
- •- Any patient in whom the use of the implant would conflict with the anatomical structures.
- •- Missing bony structures that make good anchorage of the implant impossible (e.g. fractures, tumours, osteoporosis or infections.)
- •Relative contraindications
- •- Overweight of the patient
- •- Malformations
- •- Fever or leukocytosis
- •- Systemic diseases and metabolic disorders
- •- Unbalanced diet, drug abuse, nicotine, alcohol, drug use
- •- Physical activities involving severe shocks and/or excessive stress on the implant (e.g. heavy physical work, competitive sports, marathons, alpine skiing, jumping and team sports).
- •- Patient who is mentally incapable of understanding and following the doctor's instructions.
- •- Operations on pregnant women should be avoided if possible or require special care or procedure.
- •This is at the discretion of the surgeon. Any condition that could preclude the potential benefit of spinal implantation must be clarified by the applying physician. These could be: tumours, local fractures in the area of the surgical site, unexplained elevation of the erythrocyte sedimentation rate due to other diseases, elevation of leukocytes or a significant shift in the differential blood count or other parameters.
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