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

Peking University

Status: Unknown

Conditions: Large Segmental Bone Defect

Treatments: Device: 3D printed titanium implant

Study type: Interventional

Funder types: Other

Identifiers

NCT03941028

Z181100001718195

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

bone defects caused by trauma

Experimental group

Description:

Large bone defects (\>6cm) caused by trauma

Treatment:

Device: 3D printed titanium implant

bone defects caused by infection

Experimental group

Description:

Large bone defects caused by chronic osteomyelitis

Treatment:

Device: 3D printed titanium implant

bone defects caused by tumor

Experimental group

Description:

Large bone defects caused by benign tumor

Treatment:

Device: 3D printed titanium implant