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 | Not Yet Recruiting DMC

• 1 other identifier: VINUNI-MD-2026-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bone defect reconstruction; Patient-specific implants; Three-dimensional (3D) printing; Titanium alloy Ti-6Al-4V

Outcome Measures

Primary Outcomes (8)

• 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.

  1-4 weeks postoperatively and from 6 weeks up to 12 months postoperatively

• 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.

  Within 4 weeks postoperatively

• 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.

  Within 4 weeks postoperatively

• 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.

  From 6 weeks up to 12 months postoperatively

• Change in C-reactive Protein (CRP) Level

  CRP levels (mg/L) will be measured using standard laboratory blood tests as an indicator of systemic inflammatory response following implantation.

  Within 4 weeks postoperatively and from 6 weeks up to 12 months postoperatively

• Change in White Blood Cell (WBC) Count

  WBC count (×10⁹/L) will be measured using standard hematology tests as an indicator of infection or systemic inflammatory response.

  Within 4 weeks postoperatively and from 6 weeks up to 12 months postoperatively

• Operative Time

  Duration of the surgical procedure measured in minutes, recorded from surgical records.

  Intraoperative period

• Estimated Blood Loss

  Estimated intraoperative blood loss measured in milliliters (mL), recorded from surgical records.

  Intraoperative period

Secondary Outcomes (7)

• Number of Participants with Implant Stability (No Implant Loosening)

  At 3, 6, and 12 months postoperatively

• Rate of Successful Bone-Implant Integration on Imaging

  At 3, 6, and 12 months postoperatively

• Number of Participants with restoration of Anatomical Structure

  Postoperative period and at 12 months postoperatively

• Change in Pain Score Measured by Visual Analog Scale (VAS)

  Baseline and at 1, 3, 6, and 12 months postoperatively

• Change in Functional Outcome Score

  Baseline and at 3, 6, and 12 months postoperatively

Study Arms (1)

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

EXPERIMENTAL

Participants in this arm will undergo surgical reconstruction of bone defects using patient-specific implants fabricated from titanium alloy (Ti-6Al-4V) through three-dimensional (3D) printing technology. Implants are designed based on preoperative imaging data (CT ± MRI) and manufactured using laser powder bed fusion/selective laser melting. The study evaluates the safety, feasibility, and early clinical outcomes of these customized implants during a 12-month follow-up period.

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

Interventions

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

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-

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Willing to comply with scheduled follow-up visits and study assessments

You may not qualify if:

• 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
• Participation in another interventional clinical study that may interfere with the outcomes of this study
• Inability to complete follow-up assessments within the required timeframe

Sponsors & Collaborators

• VinUniversity: lead
• Vinmec Healthcare System: collaborator

Study Sites (1)

3D Technology in Medicine Center (3D Lab, VinUni)

Hanoi, 100000, Vietnam

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Trung Dzung Tran, Professor, PhD, MD

CONTACT

+84983762005; dung.tt@vinuni.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: April 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-01

Locations

VN (1)