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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D printed implants reconstruction group | The patients with large bone defects who treated by 3D printed individualized porous implants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D printed individualized porous implants | Device | Use 3D printed individualized porous implants to reconstruct the large bone defects caused by tumor, infection or trauma. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biomechanical stability | 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. | Immediate after the bone defect reconstruction. |
| Biomechanical stability | 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. | 2 months after the bone defect reconstruction. |
| Biomechanical stability | 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. | 5 months after the bone defect reconstruction. |
| Biomechanical stability | 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. | 8 months after the bone defect reconstruction. |
| Biomechanical stability | 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. | 14 months after the bone defect reconstruction. |
| Measure | Description | Time Frame |
|---|---|---|
| Osseointegration | Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants. | Immediate after the bone defect reconstruction. |
| Osseointegration |
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Inclusion Criteria:
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The patients with bone tumor or bone infection who are diagnosed with large bone defects after receiving surgery in our Peking University Third Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teng Zhang, PhD | Contact | 8613385347899 | zhangtengdoc@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhongjun Liu, Bachelor | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | China |
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| Biomechanical stability |
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. |
| 20 months after the bone defect reconstruction. |
Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants. |
| 2 months after the bone defect reconstruction. |
| Osseointegration | Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants. | 5 months after the bone defect reconstruction. |
| Osseointegration | Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants. | 8 months after the bone defect reconstruction. |
| Osseointegration | Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants. | 14 months after the bone defect reconstruction. |
| Osseointegration | Evaluate the osseointegration characteristics of the bone-implant complex by using CT scan to quantify the callus bridging at the outer surface of the implants or the bone growing into the porous implants. | 20 months after the bone defect reconstruction. |