Allograft Alone Versus Allograft With Bone Marrow Concentrate for the Healing of the Instrumented Posterolateral Lumbar Fusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- The improvement of the fusion of the posterolateral fusion measured on X-rays
研究概览
简要总结
The use of autologous mesenchymal stem cell (MSCs) in form of the BMC in combination with allograft is an effective option how to enhance the Posterolateral Fusion (PLF) healing. Allograft by itself is not an effective material as a posterior onlay graft for the PLF in adult surgery.
详细描述
The study was prospective, randomized, controlled and blinded. Eighty patients with degenerative disease of the lumbar spine underwent instrumented lumbar or lumbosacral PLF. In forty cases, the PLF was done with spongious allograft chips alone (Group I). In another forty cases, spongious allograft chips were mixed with BMC (Group II), where the mesenchymal stem cell (MSCs) concentration was 1.74 x104/L at average (range, 1.06-1.98 x104/L). Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •degenerative disc disease or degenerative spondylolisthesis
排除标准
- •vertebral fractures,
- •infections or spinal neoplasms,
- •non-rigid instrumentations,
- •medication affecting bone mineralization (e.g., corticosteroids),
- •body mass index higher than 35,
- •systemic diseases,
- •blood disease and/or immunosuppressant treatment and/or dicoumarol therapy;
- •immunosuppressant and/or neoplastic and/or infectious diseases.
结局指标
主要结局
The improvement of the fusion of the posterolateral fusion measured on X-rays
时间窗: 12 months after the surgery
Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.
The improvement of the fusion of the posterolateral fusion measured on X-rays and CT scans.
时间窗: 24months after the surgery
Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.
次要结局
未报告次要终点
研究者
Komzak Martin, M.D.
Principal Investigator
Hospital Znojmo