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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical effect of 3D printed magnesium alloy prosthesis for repairing proximal humerus bone defect. | Experimental | The 3D printed magnesium alloy prosthesis is used to repair the proximal humerus fracture with bone defect, and the dynamic process of prosthesis degradation, fracture healing and new bone growth will be observed. |
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| Clinical effect of 3D printed magnesium alloy prosthesis for repairing distal radius bone defect. | Experimental | The 3D printed magnesium alloy prosthesis is used to repair the distal radius fracture with bone defect, and the dynamic process of prosthesis degradation, fracture healing and new bone growth will be observed. |
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| Clinical effect of 3D printed magnesium alloy prosthesis for repairing tibial plateau bone defect. | Experimental | The 3D printed magnesium alloy prosthesis is used to repair the tibial plateau fracture with bone defect, and the dynamic process of prosthesis degradation, fracture healing and new bone growth will be observed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D printed WE43 magnesium alloy | Device | This 3D printed WE43 magnesium alloy has porous structure and suitable mechanical strength, can be stable in the bone support, and gradually degrade to promote bone healing. |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of Magnesium alloy metabolism | Blood routine, electrolyte, liver and kidney function, urine routine were used to evaluate magnesium alloy metabolism in vivo. | 1, 3, 6, 12, 24 months after surgery |
| Degradation of 3D printed magnesium alloy prosthesis | X-ray and computed tomography (CT) scans were used to evaluate the degradation progression of 3D printed magnesium alloy prosthesis | 1, 3, 6, 12, 24 months after surgery |
| New bone regeneration | X-ray and CT scans were used to evaluate the process of new bone regeneration | 1, 3, 6, 12, 24 months after surgery |
| Evaluation of shoulder joint function | 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. | 1, 3, 6, 12, 24 months after surgery |
| Evaluation of wrist joint function | 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. | 1, 3, 6, 12, 24 months after surgery |
| Evaluation of knee joint function | 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. | 1, 3, 6, 12, 24 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yun Tian, MD | Contact | 010-82267010 | tiany@bjmu.edu.cn | |
| Bingchuan Liu, MD | Contact | 010-82267012 | liubc@bjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Haidian | China |
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| Peking University Third Hospita | Recruiting | Beijing | 100083 | China |
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