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Titanium implants under review: do they hold up over time?

NCT ID NCT06910033

Knowledge-focused Sponsor: Materialise 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks back at medical records of 200 people who received custom titanium implants to repair defects in the skull or face. The goal is to see how well the implants work and how safe they are over the long term. Participants include children, teens, and adults who had the surgery as part of their normal care.

Why investors are watching

Materialise is running a retrospective study of its porous titanium implants for skull and face reconstruction, tracking safety and performance across 200 children, teens, and adults. For a small-cap company, this readout matters because it tests the long-term reliability of a core product line, and a clear result could support broader adoption in a niche surgical market.

If it works: A positive result could strengthen the evidence base for these implants, which may help Materialise win more hospital contracts and expand use across age groups. That could translate into steadier revenue from a product already in clinical use.

If it fails: If the study shows poor long-term outcomes or safety issues, it could hurt the product's reputation and sales. Trials and retrospective reviews can also face delays or data problems, and a weak result would leave the company without a key marketing point.

AI-written from the trial record. Speculative, and not investment advice.

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.

Participants

About 200 people

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

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Retrospective collection of a minimum of 200 patients that were treated between 2016 and 2023 with patient-specific CMF Porous Titanium Implants for facial and/or cranial reconstruction or restoration of bone defects. All patients included in the study underwent standard visits and follow-up assessments in-hospital.

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: * Age: Patients of any age are eligible for this study. * Patients treated with Materialise patient-specific CMF Porous Titanium Implants for facial and/or cranial reconstruction. * Patients who have followed Standard of Care, as determined in each case by the treating surgeon. Exclusion Criteria: * Known hypersensitivity to Titanium at the time of surgery. * Patients who had or will receive the TMJ Total Arthroplasty System. * Pregnancy at the time of surgery.

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Conditions

The condition(s) this trial relates to.

craniofacial and skeletal defects

As listed by the trial registrant

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

Craniofacial defects

How to take part

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

  1. The places running it

    2 sites in 2 countries. 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

  • Hôpital Pitié-Salpêtrière

    Paris, France

  • Rigshospitalet

    Copenhagen, Denmark

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