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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04466397
Enrollment
60
Registered
2020-07-10
Start date
2018-06-01
Completion date
2021-06-01
Last updated
2020-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Large Bone Defects

Keywords

large bone defects, 3D printed individualized porous implant, implant-bone interface fusion

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.

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.

Interventions

DEVICE3D printed individualized porous implants

Use 3D printed individualized porous implants to reconstruct the large bone defects caused by tumor, infection or trauma.

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Biomechanical stabilityImmediate 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

MeasureTime frameDescription
OsseointegrationImmediate 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.

Countries

China

Contacts

Primary ContactTeng Zhang, PhD
zhangtengdoc@163.com8613385347899

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026