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

Not Applicable
Conditions
Large Segmental Bone Defect
Interventions
Device: 3D printed titanium implant
Registration Number
NCT03941028
Lead Sponsor
Peking University Third Hospital
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
20
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
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Exclusion Criteria
  • malignant tumor
  • patients with bad conditions failing to tolerate surgery
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
bone defects caused by infection3D printed titanium implantLarge bone defects caused by chronic osteomyelitis
bone defects caused by tumor3D printed titanium implantLarge bone defects caused by benign tumor
bone defects caused by trauma3D printed titanium implantLarge bone defects (\>6cm) caused by trauma
Primary Outcome Measures
NameTimeMethod
Bone reconstruction1 year

X-rays and CT scans are used to evaluate the bone reconstruction

Secondary Outcome Measures
NameTimeMethod
Questionnaire of limb function1 year

Restoration of limb function.

Trial Locations

Locations (1)

Peking University Third Hospital

🇨🇳

Beijing, Beijing, China

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