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

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ClinicalTrials.gov Identifier: NCT04466397
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Peking University Third Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Large Bone Defects Device: 3D printed individualized porous implants

Detailed Description:
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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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Repair of the Large Bone Defects Through 3D Printed Individualized Porous Implant: a New "Implant-bone" Interface Fusion Concept for Large Bone Defects Treatment
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Group/Cohort Intervention/treatment
3D printed implants reconstruction group
The patients with large bone defects who treated by 3D printed individualized porous implants
Device: 3D printed individualized porous implants
Use 3D printed individualized porous implants to reconstruct the large bone defects caused by tumor, infection or trauma.




Primary Outcome Measures :
  1. Biomechanical stability [ Time Frame: Immediate 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.

  2. Biomechanical stability [ Time Frame: 2 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.

  3. Biomechanical stability [ Time Frame: 5 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.

  4. Biomechanical stability [ Time Frame: 8 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.

  5. Biomechanical stability [ Time Frame: 14 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.

  6. Biomechanical stability [ Time Frame: 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.


Secondary Outcome Measures :
  1. Osseointegration [ Time Frame: Immediate 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. Osseointegration [ Time Frame: 2 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.

  3. Osseointegration [ Time Frame: 5 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.

  4. Osseointegration [ Time Frame: 8 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.

  5. Osseointegration [ Time Frame: 14 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.

  6. Osseointegration [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients with bone tumor or bone infection who are diagnosed with large bone defects after receiving surgery in our Peking University Third Hospital.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466397


Contacts
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Contact: Teng Zhang, PhD 8613385347899 zhangtengdoc@163.com

Locations
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China
Peking University Third Hospital Recruiting
Beijing, China
Contact: Teng Zhang, PhD    8613385347899    zhangtengdoc@163.com   
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Principal Investigator: Zhongjun Liu, Bachelor Peking University Third Hospital
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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT04466397    
Other Study ID Numbers: Liuzhongjun-1
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University Third Hospital:
large bone defects
3D printed individualized porous implant
"implant-bone" interface fusion