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

Peking University

Status: Enrolling

Conditions: Degradation of Magnesium Alloy Prosthesis and New Bone Regeneration

Treatments: Device: 3D printed WE43 magnesium alloy

Study type: Interventional

Funder types: Other

Identifiers

NCT06349629

20240401

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Clinical effect of 3D printed magnesium alloy prosthesis for repairing proximal humerus bone defect.

Experimental group

Description:

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.

Treatment:

Device: 3D printed WE43 magnesium alloy

Clinical effect of 3D printed magnesium alloy prosthesis for repairing distal radius bone defect.

Experimental group

Description:

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.

Treatment:

Device: 3D printed WE43 magnesium alloy

Clinical effect of 3D printed magnesium alloy prosthesis for repairing tibial plateau bone defect.

Experimental group

Description:

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.

Treatment:

Device: 3D printed WE43 magnesium alloy