Application of Platelet-Rich-Plasma in Posterolateral Lumbar Fusion
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 主要终点
- Lenke classification of posterolateral fusion success
研究概览
简要总结
The objective of this study is to evaluate the fusion rate after the use of platelet rich plasma with autolgus bone graft and comparing it with bone graft alone
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.
A total of 104 patients treated with single level degenerative or lytic lumbar Spondylolisthesis indicated for PLF will be included ,patients will be classified into 2 groups Group A:Of 52 patients PLF + autologus bone graft+ PRP Group B: Of 52 patients treated with PLF + autologus bone graft only without adding PRP
Methods of evaluation
- History taking.
- Full clinical and neurological examination
- Radiological evaluation by x-ray (antero posterior, lateral, and, CT scans provide excellent views of bony detail) and MRI if needed Method of randomization By shuffling cards method the candidate patient will choose one card from104 cards 52 of them containing fusion with PRP and the other 52 contaning Fusion without PRP
Platelet-rich plasma (PRP 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •degenerative or lytic Spondylolisthesis.
- •Degenerative disc disease requiring posterior lumbar fusion not responding to medical treatment for 1 year.
- •Age between 20 & 75 years.
- •Single level fusion
排除标准
- •Multiple levels patient Traumatic Spondylolisthesis Previous lumbar spine surgery. Other lumbar spine pathology severe osteoporosis Patients younger than 20 years old. Patients older than 75 years old. Immunocompromised patients (eg. Chronic renal failure)
研究组 & 干预措施
posteriolateral lumbar fusion +bone graft+ PRP
the addition of autologous platelet rich plasma to the bone graft
干预措施: autologous platelet rich plasma (Biological)
posteriolateral lumbar fusion+bone graft only
posteriolateral lumbar fusion with adding autologus bone graft alone posteriolateral lumbar fusion only
干预措施: posteriolateral lumbar fusion only (Procedure)
结局指标
主要结局
Lenke classification of posterolateral fusion success
时间窗: 6 month to1 year post-operative
the degree of bridging bone across the fused vertebral bodies by using xray and CT scan
次要结局
- modified Oswestry disability index ,(6 month to 1 year post-operative)
- visual analogue scale(6 month to 1 year post-operative)
研究者
Micheal Bassem Elia
orthopedics resident
Assiut University