The Clinical Study of 3D-printed Magnesium Alloy Prosthesis With Controllable Degradation Rate in the Repair of Periarticular Bone Defects

Not Applicable

Recruiting

Conditions: Degradation of Magnesium Alloy Prosthesis and New Bone Regeneration

Brief Summary: 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

Recruitment & Eligibility

Inclusion Criteria

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 70.
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.

Exclusion Criteria

Patients with pathological fracture ② pregnant women ③ doctors evaluated other conditions that were not suitable for inclusion

Arm && Interventions

Group	Intervention	Description
Clinical effect of 3D printed magnesium alloy prosthesis for repairing distal radius bone defect.	3D printed WE43 magnesium alloy	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.
Clinical effect of 3D printed magnesium alloy prosthesis for repairing tibial plateau bone defect.	3D printed WE43 magnesium alloy	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.
Clinical effect of 3D printed magnesium alloy prosthesis for repairing proximal humerus bone defect.	3D printed WE43 magnesium alloy	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of shoulder joint function	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	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	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method

Locations (2): Peking University Third Hospital
🇨🇳
Beijing, Haidian, China
Peking University Third Hospita
🇨🇳
Beijing, China