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
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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