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临床试验/NCT04466397
NCT04466397Unknown不适用

Repair of the Large Bone Defects Through 3D Printed Individualized Porous Implant: a New "Implant-bone" Interface Fusion Concept for Large Bone Defects Treatment

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Biomechanical stability

研究概览

简要总结

The aim of this study was to investigate the simply use of three-dimensional (3D) printed individualized porous implants in the absence of autogenous/allogeneic bone graft or any osteoinductive agents to treat the large bone defects caused by varies of pathogenesis and systematically study its long-term therapeutic effect and osseointegration characteristics.

详细描述

A selection of fifty-eight patients with large bone defects caused by tumor, infection or trauma received the individualized porous implants treatment, and two typical cases were chosen for detailed study. Further, the large segmental femur defect model of sheep was utilized to study the osseointegration characteristics of the individualized porous implants in 1, 3, 6 months after implantation.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Large bone defects (>4cm) in spine, limb bone and hip joint caused by tumor, infection or other pathogenesis received the individualized porous implants treatment.

排除标准

  • Bone defects less than 4cm long.
  • Bone defects treated by other methods ,such as ilizarov technique, masquelet technique or Ti mesh.

结局指标

主要结局

Biomechanical stability

时间窗: 20 months after the bone defect reconstruction.

Evaluete the immediate and long-term biomechanical stability of the bone-implant complex after surgery by the following indicator: the loosening, subsidence, displacement of the implants from radiographic examination and The symptoms of the patient.

次要结局

  • Osseointegration(20 months after the bone defect reconstruction.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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