Идёт набор NCT06349629

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

Без фазы С лечением Degradation of Magnesium Alloy Prosthesis and New Bone Regeneration

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: 3D printed WE43 magnesium alloy.
Кому может быть актуально: Состояния в реестре: Degradation of Magnesium Alloy Prosthesis and New Bone Regeneration. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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

Вмешательства

Устройство 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.

Первичные конечные точки

Detection of Magnesium alloy metabolism [Срок оценки: 1, 3, 6, 12, 24 months after surgery]
Degradation of 3D printed magnesium alloy prosthesis [Срок оценки: 1, 3, 6, 12, 24 months after surgery]
New bone regeneration [Срок оценки: 1, 3, 6, 12, 24 months after surgery]
Evaluation of shoulder joint function [Срок оценки: 1, 3, 6, 12, 24 months after surgery]
Evaluation of wrist joint function [Срок оценки: 1, 3, 6, 12, 24 months after surgery]
Evaluation of knee joint function [Срок оценки: 1, 3, 6, 12, 24 months after surgery]

Критерии участия

Критерии включения

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.