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New spinal implant aims to ease back pain from worn discs

NCT ID NCT05997121

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing the safety and performance of a spinal implant called the Hexanium TLIF system in adults with degenerative disc disease. The implant is placed during surgery to fuse the spine and restore disc height. Researchers will track pain, disability, and any serious side effects for up to two years after surgery. The goal is to see if this device helps patients feel better and function more normally.

What this could mean

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

Active substance
Hexanium TLIF system (a spinal implant device used in surgery to fuse vertebrae)
What this could lead to
If successful, this could confirm that the Hexanium TLIF system is a safe and effective option for treating degenerative disc disease, helping patients experience less back and leg pain and improved function.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. Risks include surgery-related complications like infection or implant failure, and the device may not work for everyone.

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 187 people

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

Started

Jul 2021

Expected to finish

Oct 2027

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

All patients eligible for treatment or already treated with the Hexanium TLIF system device will be offered to participate in the study; this applies to primary care clinic.

Ages

18 years and older

Sex

Anyone

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: * Patient planned for Hexanium TLIF system implant or patient implant with Hexanium TLIF system (not prior to July 2021) * Patient of 18 years old or more * Patient has provided signed informed consent, or did not oppose to his/her data collection, per local regulation Exclusion Criteria: contra-indication * Infection, local to the operative site * Signed of local inflammation * Fever or leukocytosis * Morbid obesity * Pregnancy * Paediatric cases, or patient still having general skeletal growth * Spondylolisthesis unable to be reduced to Grade I * Suspected or documented allergy or intolerance to metal * Any case where the implant components selected for use would be too large or too small to achieve a successful result * Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality * Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance * Prior fusion at the level to be treated * Any case not needing a bone graft or fusion * Any abnormality present which affects the normal process of bone remodelling including, but not limited to severe osteoporosis involving spine, bone absorption, osteopenia, primary or metastasis tumours involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis * Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumours or congenital abnormalities, fracture local to operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count * Mental illness * Any patient unwilling to cooperate with post-operative instructions

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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 Nancy

    RECRUITING

    Nancy, France

  • Clinicque Générale Beaulieu

    NOT_YET_RECRUITING

    Geneva, Switzerland

  • Clinique Saint Charles

    RECRUITING

    Lyon, France

  • Clinique du dos Terrefort

    RECRUITING

    Bruges, France

  • Hopital privé Clairval

    RECRUITING

    Marseille, France

  • Polyclinique Majorelle

    RECRUITING

    Nancy, France

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