The Clinical Study of 3D-printed Magnesium Alloy Prosthesis With Controllable Degradation Rate in the Repair of Periarticular Bone Defects
Recruiting
N/AInterventional Study
Degradation of Magnesium Alloy Prosthesis and New Bone Regeneration
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Peking University Third Hospital · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 70 with certain bone fractures that need grafting. Participants will receive a new type of 3D-printed magnesium alloy implant to help repair their bone defects.
Are You a Good Fit for This Trial?
You may be able to join if
I have a traumatic bone fracture in my arm or leg that needs treatment.
I am between 18 and 70 years old.
I can sign informed consent and agree to participate.
I have no obvious reasons not to undergo surgery.
You may not be able to join if
I have a pathological fracture.
I am pregnant.
My doctor thinks I should not participate for other reasons.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 eff…
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
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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 p…
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
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