The Effect of Using Autologous Platelet Rich Plasma on Posterior Lumbar Interbody Fusion : a Randomized Comparative Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 主要终点
- bridging trabecular bone scale
研究概览
简要总结
the study aims to determine the effect of using Autologous platelet rich plasma on both the quality & rate of posterior lumbar interbody fusion & its outcome on the Patient regarding postoperative lumbar pain & functional outcome
详细描述
The study will be submitted for approval by the Ethics Committee of Faculty of Medicine, Assiut University, and written informed consent will be obtained from all patients prior to enrollment. The study population will be selected from patients attending the Department of Orthopedics and Trauma surgery, Assiut University hospitals.
Sixty patients will be selected for the study and will be randomized into two group one receiving posterior lumbar interbody fusion with Autologous platelet rich plasma and the other group will receive posterior lumbar interbody fusion without Autologous platelet rich plasma.
Methodology pre-operative preparation: Prior to the operation the selected patients will perform lumbar spine Computarised tomography and X ray films. Both the visual analogue scale of pain and the Oswestry disability index will be collected from the patients
Autologous platelet rich plasma preparation:
Autologous Platelet rich plasma is obtained using a two-stage centrifugation process.
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 (Outcomes Assessor)
盲法说明
the person performing the statistical analysis shall be masked
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spondylolisthesis.
- •Degenerative disc disease requiring posterior lumbar interbody fusion not responding to medical treatment for 1 year.
- •Age between 20 & 70 years.
- •Single or multiple level fusions.
排除标准
- •Previous lumbar spine surgery.
- •Other lumbar spine pathology
- •severe osteoporosis
- •Chronic use of steroid or non-steroidal anti-inflammatory drugs (more than one year)
- •Patients younger than 20 years old.
- •Patients older than 70 years old.
- •Immunocompromised patients (eg. Chronic renal failure)
研究组 & 干预措施
posterior lumbar interbody fusion + platelet rich plasma
the addition of autologous platelet rich plasma to the bone graft
干预措施: autologous platelet rich plasma (Biological)
posterior lumbar interbody fusion
bone graft alone
干预措施: posterior lumbar interbody fusion without autologous platelet rich plasma (Procedure)
结局指标
主要结局
bridging trabecular bone scale
时间窗: from 3 to 6 month post-operative
the degree of bridging bone across the fused vertebral bodies
次要结局
- the Oswestry disability index(from 3 to 6 month post-operative)
- visual analogue of pain(from 3 to 6 month post-operative)
研究者
Ahmed Abdelazim Abdelrahim Hassan
resident of orthopedics and trauma surgery
Assiut University