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NCT Number: NCT06349629

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

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Key information

Conditions

Degradation of Magnesium Alloy Prosthesis and New Bone Regeneration

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital, Beijing, Haidian, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
Between the ages of 18 and 70.
Sign informed consent, voluntarily participate in the study, and complete postoperative follow-up.
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

Treatment and study plan

3D printed WE43 magnesium alloy

Device

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.

Primary outcomes

Detection of Magnesium alloy metabolism

Time frame: 1, 3, 6, 12, 24 months after surgery

Blood routine, electrolyte, liver and kidney function, urine routine were used to evaluate magnesium alloy metabolism in vivo.
Degradation of 3D printed magnesium alloy prosthesis

Time frame: 1, 3, 6, 12, 24 months after surgery

X-ray and computed tomography (CT) scans were used to evaluate the degradation progression of 3D printed magnesium alloy prosthesis
New bone regeneration

Time frame: 1, 3, 6, 12, 24 months after surgery

X-ray and CT scans were used to evaluate the process of new bone regeneration
Evaluation of shoulder joint function

Time frame: 1, 3, 6, 12, 24 months after surgery

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.
Evaluation of wrist joint function

Time frame: 1, 3, 6, 12, 24 months after surgery

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.
Evaluation of knee joint function

Time frame: 1, 3, 6, 12, 24 months after surgery

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bingchuan Liu, MD

CONTACT

[email protected]

010-82267012

Yun Tian, MD

CONTACT

[email protected]

010-82267010

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2027
First posted: Apr 5, 2024
Registry last updated: Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.