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Custom 3D-Printed bone implants: a new hope for defect repair?

NCT ID NCT07540156

Disease control Sponsor: VinUniversity Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial is testing whether custom-made 3D-printed titanium implants are safe and work well for people with bone defects. Ten patients will receive an implant designed from their own CT or MRI scans. The study will track complications, implant stability, and bone healing over the first year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Patient-specific 3D-printed titanium alloy (Ti-6Al-4V) bone implant
What this could lead to
If successful, this could provide a safe, custom-fit option for repairing bone defects, potentially improving recovery and implant stability.
What could go wrong
This is a very small, early feasibility study with only 10 participants, so results may not apply widely. Risks include infection, implant loosening, or surgical complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Bone Diseases, Metabolic bone disorder osteoporosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bone defects Bone loss

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Hanoi, 100000, Vietnam

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