3D-printed magnesium alloy prosthesis for repairing bone defects
The Clinical Study of 3D-printed Magnesium Alloy Prosthesis With Controllable Degradation Rate in the Repair of Periarticular Bone Defects
This study is testing a new 3D-printed magnesium prosthesis to see if it can help heal bone defects after fractures by supporting new bone growth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 2 sites (Beijing, Haidian and 1 other locations) |
| Trial ID | NCT06349629 on ClinicalTrials.gov |
What this trial studies
This clinical study focuses on using a 3D-printed magnesium alloy prosthesis designed to repair periarticular bone defects, which are common complications following traumatic fractures. The prosthesis features a personalized design and a porous structure that allows for controlled degradation, promoting new bone regeneration while providing necessary support during the healing process. The study aims to optimize the design of this prosthesis and establish a platform for creating metamaterial pore structures that enhance its effectiveness. Patients will be monitored postoperatively to assess the outcomes of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 70 with traumatic periarticular fractures requiring bone grafting.
Not a fit: Patients with pathological fractures, pregnant women, or those with other medical conditions deemed unsuitable for inclusion will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the healing process and functional recovery for patients with complex bone defects.
How similar studies have performed: While the use of 3D-printed prostheses is gaining traction, this specific approach with magnesium alloy and controlled degradation is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Haidian and 1 other locations
- Peking University Third Hospital — Beijing, Haidian, China (Recruiting)
- Peking University Third Hospita — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Yun Tian, MD
- Email: tiany@bjmu.edu.cn
- Phone: 010-82267010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.