Evaluation of Fusion After Anterior Lumbar Interbody Fusion With a New Osteoinductive Bone Substitute Material: a First Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
The aim of this study was to determine whether instrumented anterior lumbar interbody Fusion with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2) was associated with superior radiological and clinical outcomes at 12 months follow-up compared with instrumented ALIF with homologous bone
详细描述
This randomized clinical trial included two groups of 20 mature patients with mono- or multisegmental degenerative disease of the lumbar spine who were suitable to undergo mono- or bisegmental ALIF fusion at the level L4/L5 and L5/S1 with a carbon fiber reinforced polymer ALIF cage filled with either NH-SiO2 or homologous bone (HB). Patients were followed 12 months postoperatively. The primary aim was to compare postoperative disability as measured by the Oswestry Disability Index (ODI). Secondary aims were to compare postoperative radiographic outcomes and differences in pain and quality of life between these groups.
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
- Single (Participant)
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
- •chronic low back pain
- •sensorimotor deficits
- •radiculopathy and spinal claudication symptoms, all caused by degenerative changes in the lumbar spine, which were resistant to conservative pain therapy and / or physiotherapy
排除标准
- •previous surgeries in the abdominal Region
- •previous fusion surgery in the lumbar spine.
研究组 & 干预措施
NanoBone
The participants were treated with anterior lumbar interbody fusion (ALIF) with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2)
干预措施: NanoBone (Device)
Homologous bone
The participants were treated with anterior lumbar interbody fusion (ALIF) with homologous bone
干预措施: Homologous Bone (Device)
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: 12 months after surgery
Postoperative disability as measured by the Oswestry Disability Index (ODI)
次要结局
- Fusion rate(12 months after surgery)
研究者
Mohammad ARAB MOTLAGH
MD, PhD
Johann Wolfgang Goethe University Hospital