Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT06349629

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

Led by Peking University Third Hospital · Updated on 2024-04-05

60

Participants Needed

2

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with traumatic periarticular fractures of extremities with bone defects requiring bone grafting, including distal radius fractures, proximal humerus fractures, and tibial plateau fractures
  • Age between 18 and 70 years
  • Signed informed consent, voluntary participation, and willingness to complete postoperative follow-up
  • No obvious surgical contraindications and no contraindications for magnesium alloy prosthesis implantation
Not Eligible

You will not qualify if you...

  • Patients with pathological fractures
  • Pregnant women
  • Other conditions assessed by doctors that make participation unsuitable

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Peking University Third Hospital

Beijing, Haidian, China

Actively Recruiting

2

Peking University Third Hospita

Beijing, China, 100083

Actively Recruiting

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Research Team

Y

Yun Tian, MD

CONTACT

B

Bingchuan Liu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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