Personalized Titanium Plate Improves Clinical Outcome in Microwave Ablation of Bone Tumors Around the Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 主要终点
- Musculoskeletal Tumor Society score
研究概览
简要总结
Microwave ablation of bone tumors is time-consuming and usually results in postoperative fractures. Hence the investigators designed and fabricated a titanium plate customized to the patient's bone structures for fixation after the removal of tumorous tissue, to improve the clinical outcomes of microwave ablation.
详细描述
3D models of tumor-bearing bone segments were constructed by using computed tomography (CT) and magnetic resonance imaging (MRI). The 3D models were used to design the model of personalized titanium plates. The model of the plates was transferred into a numerical control machine for manufacturing the personalized titanium plates by 3D printing technology. The plates were then surgically implanted for reconstruction assistance following microwave-induced hyperthermia to remove the bone tumor. Implementation parameters and knee function were then evaluated.
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
- 5 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of primary malignant bone tumors in the distal femur or proximal tibia according to the preoperative biopsy.
- •Malignant soft tissue tumor invading distal femur or proximal tibia.
- •The patients have the opportunity of limb salvage and treatment of microwave-induced hyperthermia in situ and reconstruction with internal fixation.
排除标准
- •Distant metastasis.
- •Benign tumor.
- •Metastatic tumor around the knee.
- •No indication of limb salvage.
- •Malignant soft tissue tumor without bone invasion.
- •Recrudescent tumors.
结局指标
主要结局
Musculoskeletal Tumor Society score
时间窗: An average of 29 months
Mean maximum flexion of the knee
时间窗: An average of 29 months
The six degrees of freedom of the gait
时间窗: An average of 29 months
including flexion/extension, adduction/abduction, internal/external rotation, anteroposterior translation, distal/lateral translation, medial/lateral translation
次要结局
- Mean operation time(Time when the operation was begun)
研究者
Yu Zhang
Principal Investigator, Clinical Professor
Guangzhou General Hospital of Guangzhou Military Command