Clinical Effects of Large Segmental Bone Defects Caused by Trauma, Infection and Tumor With 3D Printed Titanium Implant
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Bone reconstruction
研究概览
简要总结
The investigators apply 3D printed titanium implant to treat bone defects. Without using bone grafts and growth factors, the investigators anticipate the titanium implant alone can help bone reconstruction.
详细描述
The investigators treat large segmental bone defects caused by three reasons, including trauma, infection and tumor. In this study, polyporous 3D printed titanium implant is applied to reconstruct the bone defects and the investigators will follow up patients' function and bone regeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •bone defects caused by trauma or infection or tumor
- •the length of bone defect is more than 6cm
- •more than 18 years old
排除标准
- •malignant tumor
- •patients with bad conditions failing to tolerate surgery
研究组 & 干预措施
bone defects caused by trauma
Large bone defects (>6cm) caused by trauma
干预措施: 3D printed titanium implant (Device)
bone defects caused by infection
Large bone defects caused by chronic osteomyelitis
干预措施: 3D printed titanium implant (Device)
bone defects caused by tumor
Large bone defects caused by benign tumor
干预措施: 3D printed titanium implant (Device)
结局指标
主要结局
Bone reconstruction
时间窗: 1 year
X-rays and CT scans are used to evaluate the bone reconstruction
次要结局
- Questionnaire of limb function(1 year)