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Bone cement safety confirmed in Real-World spine surgery study

NCT ID NCT06367582

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at how safe and effective bone cements are for treating spine fractures caused by osteoporosis or injury. About 500 adults who receive these cements during vertebroplasty, kyphoplasty, or screw augmentation will be followed. The goal is to confirm that these products, already used for years, work well in real-life settings.

What this could mean

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

Active substance
bone cement (SPINEFIX, HIGH V+, OPACITY+, F20)
What this could lead to
If successful, this study will confirm that these bone cements are safe and work well for treating spine fractures in everyday medical practice.
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 500 people

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

Started

Sep 2019

Expected to finish

Sep 2039

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

Adult patients suffering from painful vertebral compression fractures resulting from osteoporosis, benign or malignant lesions, or of traumatic origin

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 Ethic Committee (when applicable) or not being opposed to the use of their clinical data in the study o For prospective inclusion: * Be considered for treatment with one of the TEKNIMED Spine Range cement comprised in this study o For retrospective inclusion: * Have undergone a surgery with a TEKNIMED Spine Range cement between the 1st of January 2016 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 or be willing to sign an informed consent during the first follow-up visit following the site initiation (when applicable). Exclusion Criteria: Patients presenting one of the following conditions will not be included (contraindications per IFU): * Procedures other than those stated in the INDICATIONS section * Coagulation disorders, or severe cardiopulmonary disease * Unstable vertebral fractures * Compromise of the vertebral body or of the pedicle walls * Hypersensitivity or allergy to one of the constituents of the product * Patient clearly improving on more conservative treatment * Prophylactic use in spinal metastatic or osteoporotic patients with no evidence of acute fracture * Paediatric patients and pregnant or breast-feeding women.

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Conditions

The condition(s) this trial relates to.

Fractures, Compression Osteoporotic Fractures spinal fracture

As listed by the trial registrant

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

Compression fracture Osteoporotic fractures Vertebral fracture

How to take part

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

  1. The places running it

    12 sites in 4 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

  • CHU HautePierre

    RECRUITING

    Strasbourg, Bas-Rhin, 67200, France

  • Centre Hospitalier Métropole Savoie

    RECRUITING

    Chambéry, Savoie, 73000, France

  • Clínica Teknon Instituto de neurociencias

    RECRUITING

    Barcelona, 08022, Spain

  • Fundacio Assistencial Mutua de Terrassa - Edifici Estació

    RECRUITING

    Terrassa, 08222, Spain

  • Hospital Clínico Universitario Virgen de la Arrixaca

    RECRUITING

    Murcia, 30120, Spain

  • Hospital Neurotraumatologico

    RECRUITING

    Granada, 18013, Spain

  • Hospital de Zafra

    RECRUITING

    Zafra, 06300, Spain

  • Hospitale Cruz Vermelha Portuguesa

    RECRUITING

    Lisbon, 1549-008, Portugal

  • Hôpital Toulouse Purpan

    RECRUITING

    Toulouse, Haute Garonne, 31130, France

  • Institute of Traumatology and Orthopaedics

    RECRUITING

    Kiev, 1601, Ukraine

  • Pôle Rachis Hôpital Privé d'Eure et Loir

    RECRUITING

    Mainvilliers, Eure et Loir, 28300, France

  • Pôle Sud Santé

    RECRUITING

    Le Mans, Sarthe, 72100, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.