New implant aims to ease neck pain from disc disease
NCT ID NCT06155409
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study follows 148 adults with cervical disc disease who received the Hexanium ACIF implant, a device placed between vertebrae to restore height and fuse the spine. Researchers will track pain, disability, and any serious side effects for up to 24 months after surgery. The goal is to confirm the implant is safe and works as intended.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hexanium ACIF implant (a cage placed between vertebrae to restore height and fuse the spine)
- What this could lead to
- If successful, this could confirm that the Hexanium ACIF implant is a safe and effective option for treating cervical disc disease, reducing pain and disability.
- What could go wrong
- This is an observational study, not a randomized trial, so results may be less definitive. Risks include infection, implant failure, or no improvement in symptoms.
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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148 people
The number who actually took part.
- Started
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Jul 2021
- Expected to finish
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Jul 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 elligible for treatment or already treated with the Hexanium ACIF 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
- Healthy volunteers
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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 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 ACIF system implant or patient implanted with Hexanium ACIF system (not prior July 2020) * 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 * Signs 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 postoperative 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.
Contacts and locations
Locations
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CHRU de Nancy
Nancy, 54000, France
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Centre Hospitalier Privé de l'Europe
Le Port-Marly, 785620, France
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Clinique du Dos Terrefort
Bordeaux, 33520, France
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Hôpital Privé du Dos Francheville
Périgueux, 24000, France
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Hôpital Robert Schuman - UNEOS
Vantoux, 57070, France
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Polyclinique Majorelle
Nancy, 54000, France
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