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

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

Study Overview

• Status: Recruiting
• Conditions: Degradation of Magnesium Alloy Prosthesis and New Bone Regeneration
• Intervention / Treatment: Device: 3D printed WE43 magnesium alloy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yun Tian, MD; Phone Number: 010-82267010; Email: tiany@bjmu.edu.cn
• Study Contact Backup: Name: Bingchuan Liu, MD; Phone Number: 010-82267012; Email: liubc@bjmu.edu.cn

Study Locations

• China
  • Beijing, China, 100083
    • Recruiting
    • Peking University Third Hospita
    • Contact: Yun Tian, M.D; Phone Number: +8613701053505; Email: tiany@bjmu.edu.cn
  • Haidian
    • Beijing, Haidian, China
      • Recruiting
      • Peking University Third Hospital
      • Contact: Bingchuan Liu; Phone Number: +86 18310188678; Email: liubc@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinical effect of 3D printed magnesium alloy prosthesis for repairing proximal humerus bone defect.; 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.	Device: 3D printed WE43 magnesium alloy; This 3D printed WE43 magnesium alloy has porous structure and suitable mechanical strength, can be stable in the bone support, and gradually degrade to promote bone healing.
Experimental: Clinical effect of 3D printed magnesium alloy prosthesis for repairing distal radius bone defect.; 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.	Device: 3D printed WE43 magnesium alloy; This 3D printed WE43 magnesium alloy has porous structure and suitable mechanical strength, can be stable in the bone support, and gradually degrade to promote bone healing.
Experimental: Clinical effect of 3D printed magnesium alloy prosthesis for repairing tibial plateau bone defect.; 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.	Device: 3D printed WE43 magnesium alloy; This 3D printed WE43 magnesium alloy has porous structure and suitable mechanical strength, can be stable in the bone support, and gradually degrade to promote bone healing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of Magnesium alloy metabolism	Blood routine, electrolyte, liver and kidney function, urine routine were used to evaluate magnesium alloy metabolism in vivo.	1, 3, 6, 12, 24 months after surgery
Degradation of 3D printed magnesium alloy prosthesis	X-ray and computed tomography (CT) scans were used to evaluate the degradation progression of 3D printed magnesium alloy prosthesis	1, 3, 6, 12, 24 months after surgery
New bone regeneration	X-ray and CT scans were used to evaluate the process of new bone regeneration	1, 3, 6, 12, 24 months after surgery
Evaluation of shoulder joint function	American Shoulder and Elbow Surgeon's Form (ASES) was used to evaluate the shoulder joint function. The score scale of this form was 0 to 100, higher score represents better shoulder joint function.	1, 3, 6, 12, 24 months after surgery
Evaluation of wrist joint function	Mayo Wrist Score was used to evaluate the wrist joint function.The score scale of this form was 0 to 100, higher score represents better joint function.	1, 3, 6, 12, 24 months after surgery
Evaluation of knee joint function	Knee Society Score (KSS) was used to evaluate the knee joint function.The score scale of this form was 0 to 100, higher score represents better joint function.	1, 3, 6, 12, 24 months after surgery

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 20240401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No