New spinal implants under observation for back pain relief

NCT ID NCT06342765

Knowledge-focused Sponsor: SPINEVISION SAS Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 330 adults who have received SpineVision spinal implants (Lumis, Plus, or Ulis) as part of their standard care for degenerative disc disease. Researchers will track pain, disability, and any side effects for up to 24 months after surgery to confirm the implants' safety and performance.

What this could mean

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

Active substance: SpineVision posterior fixation systems (Lumis, Plus, Ulis) implanted via pedicle fixation surgery
What this could lead to: If successful, this study could confirm that these spinal implants are safe and effective for treating degenerative disc disease, supporting their continued use.
What could go wrong: This is an observational study, not a controlled trial, so results may be less definitive. Risks include implant-related complications like infection or allergy.

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 330 people

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

Started

Sep 2022

Expected to finish

May 2028

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 one (1) of the SpineVision posterior fixation system (Lumis®, Plus® or Ulis®) will be offered to participate in the study; this applies to primary care clinic.

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: * Patient implanted with Lumis®, Plus® or Ulis® posterior fixation system * Patient of 18 years old and more * Patient has provided signed informed consent or did not oppose to his/her data collection, per local regulation Exclusion Criteria: contra-indication * trauma (i.e., fracture or dislocation) * Known or suspected allergy or intolerance to the implanted material, mainly to metal (e.g., cobalt, chromium, nickel, etc.) * Any other medical or surgical condition likely to compromise the success of instrumented surgery, such as the presence of a malignant tumor or serious congenital abnormalities, raised erythrocyte sedimentation rate not explained by other diseases, high white blood cell count or a tendency to low white blood cell count * All cases not described in the indications * Localized infection of the operative site * All patients with insufficient tissue cover of the operative site * Local signs of inflammation * Fever or leukocytosis * Pathological obesity * Pregnancy * Mental illness * Rapidly evolving joint diseases, bone absorption, osteopenia and/or osteoporosis. Osteoporosis is a relative contraindication, as this medical condition can limit the expected correction gain and stability of mechanical fixation * All cases not requiring bone graft or bone fusion * When pedicular screws are used, absence or malformation of pedicles * All cases requiring a combination of different metals * All patients not agreeing to comply with post-operative instructions

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Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder

As listed by the trial registrant

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

Intervertebral disc degeneration

How to take part

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

The places running it

3 sites. The list below names each one and where it is.
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.

New spinal implants under observation for back pain relief

What the study statuses mean