Core Decompression With Bone Chips Allograft Adjuvanted by Fibrin Platelet Rich-plasma (PRP) and Concentrated Autologous Mesenchymal Stromal Cells (MSCS): Results in Avascular Necrosis of Femoral Head (AVN) After 2 Years Minimum Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Avoiding arthroplasty
研究概览
简要总结
This retrospective study evaluates 52 cases of avascular necrosis of femoral head (AVN) treated by core decompression, bone chips allograft, fibrin platelet rich-plasma (PRF) and concentrated autologous mesenchymal stromal cells (MSCs).
详细描述
We report 52 cases of avascular necrosis of the hip (AVN), operated by decompression of the necrotic area with bone chips allograft, adjuvanted by concentrated autologous mesenchymal stromal cells (MSCs) and fibrin platelet rich-plasma (PRP).
The patients were followed-up at 6 weeks, 3 months, 6 months, 12 months, 24 months and then every year. Each time a clinical evaluation by Harris Hip Score (HHS) was carried out by the same orthopedic surgeon. Radiological controls (pelvis and hip affected) were performed at 6 weeks, 3 months, 6 months, 12 months, 24 months and then every year.
The primary outcome evaluated was the avoiding or delaying of total hip replacement (THR), while the secondary outcomes were the assessment of any change in clinical performance as measured by Harris Hip Score
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hip avascular necrosis
排除标准
- •protrusio acetabuli
- •concentric femoral head migration;
- •presence of extensive surgery of the reference joint (osteotomies around the hip, open or arthroscopic osteochondroplasty for femoral-acetabular impingement)
- •presence of excessive deformity (acetabular or femoral head dysplasia; collapse deformity and deformed femoral head sequelae of Perthes);
- •concomitant rheumatic diseases;
- •bone tumors
研究组 & 干预措施
Hip avascular necrosis
patients affected by avascular necrosis of the Hip classified by Japanese Investigation Committee criteria
干预措施: Core decompression procedure (Procedure)
结局指标
主要结局
Avoiding arthroplasty
时间窗: 24 months after surgery
The primary outcome evaluated was the avoiding or delaying of total hip replacement (THR)
次要结局
- Harris Hip Score(12 months after surgery)
- Harris Hip Score(6 weeks after surgery)
- Harris Hip Score(3 months after surgery)
- Harris Hip Score(6 months after surgery)
研究者
Dante Dallari, MD
MD
Istituto Ortopedico Rizzoli