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Clinical Effects of Large Segmental Bone Defects With 3D Printed Titanium Implant

Clinical Effects of Large Segmental Bone Defects Caused by Trauma, Infection and Tumor With 3D Printed Titanium Implant

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03941028
Enrollment
20
Registered
2019-05-07
Start date
2019-01-12
Completion date
2021-12-30
Last updated
2019-05-07

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

Conditions

Large Segmental Bone Defect

Brief summary

The investigators apply 3D printed titanium implant to treat bone defects. Without using bone grafts and growth factors, the investigators anticipate the titanium implant alone can help bone reconstruction.

Detailed description

The investigators treat large segmental bone defects caused by three reasons, including trauma, infection and tumor. In this study, polyporous 3D printed titanium implant is applied to reconstruct the bone defects and the investigators will follow up patients' function and bone regeneration.

Interventions

DEVICE3D printed titanium implant

The 3D printed titanium implant is fabricated by related companies. And some implants have been used in spinal disease in our hospital.

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* bone defects caused by trauma or infection or tumor * the length of bone defect is more than 6cm * more than 18 years old

Exclusion criteria

* malignant tumor * patients with bad conditions failing to tolerate surgery

Design outcomes

Primary

MeasureTime frameDescription
Bone reconstruction1 yearX-rays and CT scans are used to evaluate the bone reconstruction

Secondary

MeasureTime frameDescription
Questionnaire of limb function1 yearRestoration of limb function.

Other

MeasureTime frameDescription
Questionnaire of patients' satisfaction degree1 yearVAS score is used to evaluate the satisfaction degree. The score ranges from 0 to 10, 0 means very dissatisfied and 10 means very satisfied.

Countries

China

Contacts

Primary ContactBingchuan Liu, MD
liubc@bjmu.edu.cn+86-18310188678

Outcome results

None listed

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