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?"
Diagnosed with a bone defect requiring surgical reconstruction, as determined by the treating orthopedic surgeon
Suitable candidate for implantation of a patient-specific device manufactured from Ti-6Al-4V
Able to undergo preoperative imaging (CT ± MRI) required for implant design
Willing and able to provide written informed consent
Active systemic or local infection at the surgical site at the time of implantation
Known hypersensitivity or allergy to titanium or titanium alloys
Severe uncontrolled comorbidities that significantly increase surgical risk (e.g., uncontrolled diabetes, severe cardiovascular disease)
Pregnant or breastfeeding women
Single group
Patient-specific 3D-printed Ti-6Al-4V bone implant
DeviceThe 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-
Number of Participants with Major Postoperative Complications
Assessment of major postoperative complications related to the implant or surgical procedure (Yes/No), based on clinical examination and medical record review.
Number of Participants with Early Local Complications
Assessment of early local complications including wound discharge, bleeding, swelling, pain, and sensory disturbance, evaluated using standardized clinical examination.
Number of Participants with Early Systemic Complications
Assessment of early systemic complications including sepsis, hemodynamic instability, and respiratory failure, based on clinical evaluation and inpatient medical records.
Number of Participants with Late Implant-Related Complications
Assessment of late implant-related complications including implant loosening, sinus tract formation, and persistent pain, evaluated through clinical examination.
Number of Participants with Implant Stability (No Implant Loosening)
Assessment of implant stability defined as absence of implant loosening (Yes/No), evaluated by clinical examination and imaging (X-ray or CT).
Rate of Successful Bone-Implant Integration on Imaging
Assessment of osseointegration based on imaging findings (X-ray or CT), defined as absence of radiolucent lines and presence of a stable bone-implant interface.
Number of Participants with restoration of Anatomical Structure
Assessment of postoperative anatomical reconstruction (e.g., limb morphology) using clinical evaluation and imaging documentation.
Change in Pain Score Measured by Visual Analog Scale (VAS)
Pain intensity will be assessed using the Visual Analog Scale (VAS), a standardized 0-10 scale, with higher scores indicating greater pain.
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VinUniversity
Lead sponsor
Vinmec Healthcare System
Collaborator
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