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
VinUniversity
Lead sponsor
Vinmec Healthcare System
Collaborator