The Clinical Study of 3D-printed Magnesium Alloy Prosthesis With Controllable Degradation Rate in the Repair of Periarticular Bone Defects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Evaluation of shoulder joint function
研究概览
简要总结
Perimarticular fracture bone defect is a common and complicated clinical disease. The current treatment for this type of injury is anatomical reduction of the fracture, where the bone defect is filled with artificial, autologous or allogeneic bone in granular form, and then fixed with plates and screws. However, these bone filler materials exist in a loose accumulation state and cannot form an effective overall support force for the joint. The applicant realized three dimensional (3D) printing of WE43 magnesium alloy with personalized design and porous overall structure, and developed high-temperature heat treatment technology to slow its degradation, which effectively realized the dual stability of degradation rate of magnesium alloy support body and overall structure during the bone repair period. This project will optimize the design of 3D printed WE43 magnesium alloy full-structure in-bone support, and establish a metamaterial pore structure design platform that regulates the physical properties and degradation behavior of porous implants. Fracture from proximal humerus, distal radius and tibial plateau
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with traumatic periarticular fractures of extremities with bone defects requiring bone grafting mainly include distal radius fractures, proximal humerus fractures, and tibial plateau fractures.
- •Between the ages of 18 and
- •Sign informed consent, voluntarily participate in the study, and complete postoperative follow-up.
- •There are no obvious surgical contraindications and no contraindications for magnesium alloy prosthesis implantation.
排除标准
- •Patients with pathological fracture ② pregnant women ③ doctors evaluated other conditions that were not suitable for inclusion
结局指标
主要结局
Evaluation of shoulder joint function
时间窗: 1, 3, 6, 12, 24 months after surgery
American Shoulder and Elbow Surgeon's Form (ASES) was used to evaluate the shoulder joint function. The score scale of this form was 0 to 100, higher score represents better shoulder joint function.
New bone regeneration
时间窗: 1, 3, 6, 12, 24 months after surgery
X-ray and CT scans were used to evaluate the process of new bone regeneration
Evaluation of wrist joint function
时间窗: 1, 3, 6, 12, 24 months after surgery
Mayo Wrist Score was used to evaluate the wrist joint function.The score scale of this form was 0 to 100, higher score represents better joint function.
Detection of Magnesium alloy metabolism
时间窗: 1, 3, 6, 12, 24 months after surgery
Blood routine, electrolyte, liver and kidney function, urine routine were used to evaluate magnesium alloy metabolism in vivo.
Degradation of 3D printed magnesium alloy prosthesis
时间窗: 1, 3, 6, 12, 24 months after surgery
X-ray and computed tomography (CT) scans were used to evaluate the degradation progression of 3D printed magnesium alloy prosthesis
Evaluation of knee joint function
时间窗: 1, 3, 6, 12, 24 months after surgery
Knee Society Score (KSS) was used to evaluate the knee joint function.The score scale of this form was 0 to 100, higher score represents better joint function.
次要结局
未报告次要终点
研究者
Tian Yun
Professor
Peking University Third Hospital