The Clinical Study of 3D-printed Magnesium Alloy Prosthesis With Controllable Degradation Rate in the Repair of Periarticular Bone Defects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D printed WE43 magnesium alloy.
- Who it may be relevant to
- Registry conditions: Degradation of Magnesium Alloy Prosthesis and New Bone Regeneration. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device 3D 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.
Primary outcome measures
- Detection of Magnesium alloy metabolism [Time frame: 1, 3, 6, 12, 24 months after surgery]
- Degradation of 3D printed magnesium alloy prosthesis [Time frame: 1, 3, 6, 12, 24 months after surgery]
- New bone regeneration [Time frame: 1, 3, 6, 12, 24 months after surgery]
- Evaluation of shoulder joint function [Time frame: 1, 3, 6, 12, 24 months after surgery]
- Evaluation of wrist joint function [Time frame: 1, 3, 6, 12, 24 months after surgery]
- Evaluation of knee joint function [Time frame: 1, 3, 6, 12, 24 months after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Peking University Third Hospital — Beijing
- Peking University Third Hospita — Beijing
Identifiers
NCT: NCT06349629 · 20240401