Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a spine implant still deliver relief after 9 years?

NCT ID NCT07790328

Knowledge-focused Sponsor: Cousin Biotech 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

Researchers are following up with about 50 patients who received the IntraSPINE implant for lower back pain caused by degenerative disc disease. The goal is to see whether the implant still provides meaningful improvement in function and pain at least 9 years after surgery. They will also check for any long-term complications, such as the need for another operation or implant removal, using clinical exams and MRI scans.

What this could mean

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

Active substance
IntraSPINE, an interlaminar implant placed in the spine to treat lower back pain from degenerative disc disease
What this could lead to
If the implant shows lasting benefit and safety after 9 years, it could support its continued use as a surgical option for degenerative disc disease.
What could go wrong
This is a small observational follow-up, not a controlled trial, so results may not apply broadly. Some patients may have had complications or no lasting improvement.

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 50 people

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

Started

Jul 2020

Expected to finish

Jun 2031

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

The study population included adult patients from the Princeps study (INTREUR) who completed the 36-month follow-up. Eligible patients had degenerative lumbar disc disease at one or two levels, underwent IntraSPINE® implantation following failure of conservative treatment, and had no device removal during follow-up or underwent replacement with a new IntraSPINE® device at the 36-month visit. All patients received study information and provided written informed non-opposition.

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: * Adult patient, * Patient with degenerative lumbar disc disease at one or two levels for whom * Surgery involving the placement of an IntraSPINE® implant has been indicated following the failure of conservative treatment, * Patient who has read and signed the information and consent form Exclusion Criteria: * Patients with the following contraindications: * Allergy to any of the components, * Infected site, * Pregnant women. * Patients with spondylolisthesis with isthmic lysis

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Degenerative lumbar disc disease are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

lumbar disk degenerative disorder lumbar spinal stenosis vertebral column disorder

As listed by the trial registrant

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

Joint facet syndrome Lower back pain of disc origin Lumbar canal stenosis Spinal disease

How to take part

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

  1. The places running it

    1 site. 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

  • Maison des consultations

    RECRUITING

    Saran, France

More trials for these conditions

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