DRKS00031819尚未招募不适用
Sponsor-initiated, prospective, monocentric, non-interventional clinical observational study (AWB) to evaluate the Transmaxx® ALIF Cage in spine surgery use according to the intended purpose. - PMCF Transmaxx system
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 43
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 ability to read, understand and speak the local language fluently
- •- Signed informed consent and protocol-specific examinations
- •- The surgical indication must be one or a combination of the following.
- •Degenerative disc disease
- •Spondylolisthesis (up to Grade 1)
- •- Mono-, bi- and multisegmental treatment
- •- Age: = 18 years
- •- Surgical technique: Transmaxx® ALIF Cage und posteriore Stabilisierung
排除标准
- •Reduced bone quality (e.g. osteoporosis or bone
- •decalcification)
- •Fractures
- •Active infection
- •Local inflammation
- •Primary spinal deformities
- •Allergy to titanium or its alloys
- •Intraoperative circumstances necessitating implantation of an implant other than the implant type intended in the study (as determined by the surgeon)
研究者
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