New spinal implant aims to ease back pain from worn discs
NCT ID NCT05997121
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
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About 187 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
Show the full entry requirements Hide 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.
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The places running it
6 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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CHRU Nancy
RECRUITINGNancy, France
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Clinicque Générale Beaulieu
NOT_YET_RECRUITINGGeneva, Switzerland
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Clinique Saint Charles
RECRUITINGLyon, France
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Clinique du dos Terrefort
RECRUITINGBruges, France
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Hopital privé Clairval
RECRUITINGMarseille, France
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Polyclinique Majorelle
RECRUITINGNancy, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A conversation before spine surgery could change how patients recover
- Can a new bone graft match the gold standard for spinal fusion?
- Can a nanotube surface help spinal bones fuse faster?
- Can a growth factor from donor bone improve spinal fusion?
- 3D-Printed spinal cages could revolutionize back surgery
- Bone scan may help avoid unnecessary back surgery