Efficacy of Autologous Bone Marrow Clot as Scaffold for Instrumental Posterior Lumbar Fusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Brantigan classification
研究概览
简要总结
Bone marrow aspirate (BMA) in association to graft substitutes has long been introduced as a promising alternative to iliac crest bone graft in spinal fusion. However, BMA use is limited by the absence of a standardized technique, of a physical texture and by the possibility of dispersion away from the implant site. Recently, the potential use of a new formulation of BMA, named BMA clot, has been preclinically described. A prospective pilot clinical study designed to assessing the safety and efficacy of autologous vertebral BMA (vBMA) clot as multifunctional bio-scaffold in instrumental posterior lumbar fusion will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 over the age of 18 at the time of surgery
- •symptomatic degenerative spine disease needing posterior fusion at the lumbar tract
排除标准
- •any form of local or systemic infections, inflammatory or autoimmune disease
- •coagulation disorders
- •tumor diseases
- •alcohol or drug abuse
- •pregnancy
- •chemotherapeutic drugs that might interfere with bone regeneration processes
- •revision surgery
结局指标
主要结局
Brantigan classification
时间窗: 12 months
Improvement of spinal fusion rate and time in patients treated with vBMA clot associated to bone allograft chips in comparison to bone allograft chips alone, also considering age and gender differences. CT-scan and X-ray, perform pre-operatively and at FUs, will be evaluated basing on Brantigan classification (which ranges from A to E, with E score indicating better SF rate).
次要结局
- Visual Analogue Score(12 months)
- Oswestry Disability Index(12 months)
- EuroQoL-5L (EQ-5L)(At baseline (day 0))
- EuroQoL-5L(12 months)