ISRCTN12002403进行中（未招募）4 期
Prospective evaluation of clinical and radiographic outcomes after lumbar lateral interbody fusion surgery using a JULIET® Ti LL interbody fusion cage
Spineart (Switzerland)0 个研究点目标入组 74 人开始时间: 2022年5月12日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 74
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Skeletally mature subjects, =18 years old
- •2. Indicated DDD defined as discogenic back pain with degeneration of the disc confirmed radiographically and by patient history
- •2.1. DDD, or
- •2.2. DDD with up to grade I Spondylolisthesis, or
- •2.3. DDD with up to grade I Retrolisthesis
- •3. Psychosocially, mentally, and physically able to fully comply with the protocol including adhering to follow-up schedule and filling out questionnaires.
- •4. Written voluntary informed consent signed
排除标准
- •1. Mental illness
- •2. Infection
- •3. Severely damaged bone structures that could prevent stable implantation of the cage (bone density in SD =-2.5)
- •4. Neuromuscular or vascular disorders or illness
- •5. Inadequate activity (inability to follow postoperative rehab restriction)
- •6. Pregnancy
- •7. Bone tumor in the region of the implant
- •8. Fractures (same level treated or adjacent level: active, non-consolidated, or old osteoporotic fracture)
研究者
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