Repair of the Large Bone Defects Through 3D Printed Individualized Porous Implant

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Large Bone Defects

Intervention / Treatment
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* Device: 3D printed individualized porous implants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Large bone defects (>4cm) in spine, limb bone and hip joint caused by tumor, infection or other pathogenesis received the individualized porous implants treatment.Exclusion Criteria: Bone defects less than 4cm long. Bone defects treated by other methods ,such as ilizarov technique, masquelet technique or Ti mesh.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 3D printed implants reconstruction group<br>The patients with large bone defects who treated by 3D printed individualized porous implants | Device: 3D printed individualized porous implants<br>* Use 3D printed individualized porous implants to reconstruct the large bone defects caused by tumor, infection or trauma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 
| 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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large bone defects, 3D printed individualized porous implant, implant-bone interface fusion