Clinical trial NCT04466397: Repair of the Large Bone Defects Through 3D Printed Individualized Porous Implant
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Large Bone Defects
Keywords: large bone defects
3D printed individualized porous implant
"implant-bone" interface fusion
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Biomechanical stability
timeFrame: Immediate after the bone defect reconstruction.
measure: Biomechanical stability
timeFrame: 2 months after the bone defect reconstruction.
measure: Biomechanical stability
timeFrame: 5 months after the bone defect reconstruction.
measure: Biomechanical stability
timeFrame: 8 months after the bone defect reconstruction.
measure: Biomechanical stability
timeFrame: 14 months after the bone defect reconstruction.
measure: Biomechanical stability
timeFrame: 20 months after the bone defect reconstruction.
Secondary outcomes:
measure: Osseointegration
timeFrame: Immediate after the bone defect reconstruction.
measure: Osseointegration
timeFrame: 2 months after the bone defect reconstruction.
measure: Osseointegration
timeFrame: 5 months after the bone defect reconstruction.
measure: Osseointegration
timeFrame: 8 months after the bone defect reconstruction.
measure: Osseointegration
timeFrame: 14 months after the bone defect reconstruction.
measure: Osseointegration
timeFrame: 20 months after the bone defect reconstruction.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Zhongjun Liu, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: