Evaluation of the Safety, Feasibility, and Early Clinical Outcomes of Patient-Specific Bone Defec… (NCT07540156) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
Vietnam10 participantsStarted 2026-04-01
Plain-language 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?"
Who can participate
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
What they're measuring
1
Number of Participants with Major Postoperative Complications
Timeframe: 1-4 weeks postoperatively and from 6 weeks up to 12 months postoperatively
2
Number of Participants with Early Local Complications
Timeframe: Within 4 weeks postoperatively
3
Number of Participants with Early Systemic Complications
Timeframe: Within 4 weeks postoperatively
4
Number of Participants with Late Implant-Related Complications
Timeframe: From 6 weeks up to 12 months postoperatively
5
Change in C-reactive Protein (CRP) Level
Timeframe: Within 4 weeks postoperatively and from 6 weeks up to 12 months postoperatively
6
Change in White Blood Cell (WBC) Count
Timeframe: Within 4 weeks postoperatively and from 6 weeks up to 12 months postoperatively