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Bone graft materials under Real-World safety review

NCT ID NCT06374342

Disease control Sponsor: Teknimed Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study is following 425 people who receive Teknimed bone substitutes during surgeries like bone grafting or spinal fusion. The goal is to confirm the safety and performance of these products in everyday medical practice. Researchers will track how well the bone heals, pain levels, and whether any additional surgeries are needed.

What this could mean

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

Active substance
bone substitute (synthetic bone graft material)
What this could lead to
If successful, this study could confirm that these bone substitutes are safe and effective for routine use in bone repair surgeries.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. It mainly confirms existing safety data rather than testing a new breakthrough.

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 425 people

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

Started

Sep 2021

Expected to finish

Sep 2032

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

People presenting a bone defect created by surgical or traumatic injury.

Ages

18 years and older

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: * Be 18 years or older. * Be willing to sign an informed consent approved by IRB or EC (where applicable) or not being opposed to the use of their clinical data in the study (France) and o For prospective inclusion: * Be considered for a surgery where bone filling with one of the TEKNIMED bone substitutes comprised in this study is needed and intended to be used according to the IFU. o For retrospective inclusion: * Have undergone a surgery with a TEKNIMED bone substitute used according to the IFU, between the 1st January 2015 and the date of the site initiation visit * Be informed of the study and not being opposed to the use of their clinical data in the study (France) or be willing to sign an informed consent (where applicable) during the first follow-up visit following the site initiation. Exclusion Criteria: Patients presenting one of the following conditions will not be included: * Under trusteeship or guardianship * Pregnancy or breast-feeding women According to contraindications per IFU: * Procedures other than those stated in the INDICATIONS section * Patients susceptible to allergic reactions to the product components. CERAFORM®, TRIHA+®: \- Treatment of large bone defects which could impact the stability of bone structure without implementing a mechanical stabilisation system (such as plate(s), screw(s), nail(s), cage(s)) NANOGEL®: * Use in vertebroplasty procedures * Subcutaneous use

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Conditions

The condition(s) this trial relates to.

bone resorption disease

As listed by the trial registrant

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

Bone resorption

How to take part

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

  1. The places running it

    6 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

  • CHRU Brabois

    RECRUITING

    Nancy, Meurthe et Moselle, 54000, France

  • Clinique Médipole Garonne

    RECRUITING

    Toulouse, Haute Garonne, 31100, France

  • Clinique du Pré

    RECRUITING

    Le Mans, Sarthe, 72000, France

  • Hôpital Joseph Ducuing

    RECRUITING

    Toulouse, Haute Garonne, 31000, France

  • OCM Klinik GmbH

    RECRUITING

    München, Bavaria, D-81369, Germany

  • Pôle Rachis Hôpital Privé d'Eure et Loir

    RECRUITING

    Mainvilliers, Eure et Loir, 28300, France

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