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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Peking University Third Hospital
Beijing, Haidian, China
RECRUITINGPeking University Third Hospita
Beijing, China
RECRUITINGDetection of Magnesium alloy metabolism
Blood routine, electrolyte, liver and kidney function, urine routine were used to evaluate magnesium alloy metabolism in vivo.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1, 3, 6, 12, 24 months after surgery
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