NCT06349629 The Clinical Study of 3D-printed Magnesium Alloy Prosthesis With Controllable Degradation Rate in the Repair of Periarticular Bone Defects
| NCT ID | NCT06349629 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University Third Hospital |
| Condition | Degradation of Magnesium Alloy Prosthesis and New Bone Regeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2025-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-01-01 with a primary completion date of 2025-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06349629 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Degradation of Magnesium Alloy Prosthesis and New Bone Regeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06349629 currently recruiting?
Yes, NCT06349629 is actively recruiting participants. Contact the research team at tiany@bjmu.edu.cn for enrollment information.
Where is the NCT06349629 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT06349629 clinical trial?
NCT06349629 is sponsored by Peking University Third Hospital. The trial plans to enroll 60 participants.