Degradation of Magnesium Alloy Prosthesis and New Bone Regeneration
Conditions
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
Interventions
DEVICE3D printed WE43 magnesium alloy
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.
Sponsors
Peking University Third Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. Between the ages of 18 and 70. 3. Sign informed consent, voluntarily participate in the study, and complete postoperative follow-up. 4. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactYun Tian, MD
Backup ContactBingchuan Liu, MD
Outcome results
None listed