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Evaluation of the Safety, Feasibility, and Early Clinical Outcomes of Patient-Specific Bone Defect Implants Fabricated From Titanium Alloy (Ti-6Al-4V) Using 3D Printing Technology

NCT07540156 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-20

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and feasibility of patient-specific bone defect implants fabricated from Ti-6Al-4V using 3D printing technology and to assess early clinical outcomes within the first 12 months following implantation of these customized devices. The main question it aims to answer is: "In patients with bone defects requiring surgical reconstruction, are patient-specific bone defect implants fabricated from titanium alloy (Ti-6Al-4V) using 3D printing technology - designed and produced at VinUni, safe and feasible for clinical use, and do they result in favorable early clinical outcomes within the first 12 months following implantation?"

Conditions

  • Bone Loss
  • Bone Defects

Interventions

DEVICE

Patient-specific 3D-printed Ti-6Al-4V bone implant

The investigational device is a patient-specific bone implant manufactured from titanium alloy Ti-6Al-4V using metal additive manufacturing technology. The implant is designed individually for each patient based on medical imaging data (CT or MRI), which are converted from DICOM format into three-dimensional digital models for anatomical reconstruction and implant design. The device is fabricated using selective laser melting (SLM) technology, in which high-power laser beams selectively fuse layers of Ti-6Al-4V powder to produce the final implant geometry. The manufacturing process is performed on a metal additive manufacturing system under an inert gas environment to prevent oxidation and ensure material integrity. Titanium powder feedstock complies with ASTM F2924 specifications for medical-grade Ti-6Al-4V used in powder bed fusion processes. Following printing, implants undergo standardized post-processing procedures including support removal, surface cleaning and finishing, stress-

Sponsors & Collaborators

  • Vinmec Healthcare System

    collaborator OTHER

  • VinUniversity

    lead OTHER

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-06-30
Completion
2028-12-31

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07540156 on ClinicalTrials.gov