Lower Back Pain of Disc OriginIntraLTNCT07790328
Long-Term Evaluation of the Performance and Safety of the IntraSPINE® Interlaminar Implant in the Treatment of Lumbar Degenerative Disc Disease
An observational study of Lower Back Pain of Disc Origin and Joint Facet Syndrome, run by Cousin Biotech at 1 site in France.
Trial summary
This is an observational study designed as an extension of a prospective study conducted between 2012 and 2017. Patients who were originally enrolled in the initial study are being recontacted for follow-up assessment, including evaluation of clinical and radiological (MRI) criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Back Pain of Disc Origin, Joint Facet Syndrome, Lumbar Canal Stenosis
- What is being tested?
- IntraSPINE
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jul 2020to 1 Jun 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Patients with the following contraindications:
- Allergy to any of the components,
- Infected site,
- Pregnant women.
- Patients with spondylolisthesis with isthmic lysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Maison des consultations
Saran
Doan Co Minh, +33 02 46 91 51 10, m.collet@cousin-surgery.com
About this study
This is an observational study designed as an extension of a prospective study conducted between 2012 and 2017. Patients who were originally enrolled in the initial study are being recontacted for follow-up assessment, including evaluation of clinical and radiological (MRI) criteria. Approximately 50 patients have been included to date and their long terms results (at least 9 years) will be assessed.
- Conditions
- Lower Back Pain of Disc Origin, Joint Facet Syndrome, Lumbar Canal Stenosis, Spinal Disease
- Being tested
- IntraSPINE
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntraSPINEDrug
Also called Interlaminar device
Intraspine is an interlaminar device not interspinous.
| Study group | Role | What they receive |
|---|---|---|
| IntraSPINE | The IntraSPINE® implant is a widely used dynamic interlaminar stabilization device that differs from other inter-spinal devices (ISDs) in its structure and its more anterior positioning relative to the spinal axis.
This device is a dimethyl siloxane (silicone) implant covered with a polyethylene terephthalate mesh. Its anterior surface, which comes into contact with the ligamentum flavum (when it is left in place) or with the dura mater, is coated with an anti-adhesive coating.
The device is an elastic support with a cushioning effect. The stiffer anterior portion provides strong distraction, while the more flexible posterior tunnel acts as a stress absorber. The lateral wings secure the device in place, preventing any migration. Receives: Drug: IntraSPINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate at long term (at least 9 years)
The clinical success is defined by :
- An improvement (decrease) in the ODI score of at least 30% compared to the score at enrollment in the pivotal study
- No complications such as revision, reoperation, implant removal, infection, or any other adverse events related to the surgery or the device since enrollment in the pivotal study
Measured: At least 9 years after enrollment in the pivotal study
Secondary outcomes (22)
Degree of functional disability
The degree of functional disability associated with low back pain will be measured using the Oswestry Disability Index (ODI), a 0-100 scale in which higher scores indicate greater functional disability.
Measured: At least 9 years after enrollment in the pivotal study
Radicular and low back pain
The severity of radicular and lower back pain will be assessed using a Visual Analog Scale (VAS), ranging from 0 to 100, with higher scores indicating greater pain severity.
Measured: At least 9 years after enrollment in the pivotal study
Walking time
Walking time will be estimated by measuring the time it takes to cover the maximum possible distance
Measured: At least 9 years after enrollment in the pivotal study
Finger-to-floor test
The finger-to-floor test measures the distance between your fingers and the floor: With your feet together, slowly lean your upper body forward while arching your back, keeping your arms straight, and try to touch the floor with your fingers. It is essential not to bend your knees
Measured: At least 9 years after enrollment in the pivotal study
Disc height (anterior and posterior)
Disc height (anterior and posterior) will be measured based on the MRI results
Measured: At least 9 years after enrollment in the pivotal study
Mobility of the highest treated level and the adjacent level
The mobility of the highest treated level and the adjacent level will be measured by dynamic radiography in lateral flexion and extension. Mobility will be calculated as the angular difference between extension and flexion, based on the angles formed by the tangents to the superior and inferior endplates of the vertebral segment.
Measured: At least 9 years after enrollment in the pivotal study
Pfirmann and Modic classification
The Pfirmann and Modic classification (affected level and adjacent level) based on MRI results
Measured: At least 9 years after enrollment in the pivotal study
Patient satisfaction
Patient satisfaction with their INTRASPINE implant will be assessed on a 4-point scale: (1: Very satisfied, 2: Satisfied, 3: Somewhat dissatisfied, 4: Not at all satisfied)
Measured: At least 9 years after enrollment in the pivotal study
Number of Participants with Adjacent Syndrome
A patient is considered to have an adjacent syndrome at their follow-up visit if they meet one (or more) of these three criteria:
- Radiological adjacent syndrome: This diagnosis will be made for any patient who meets the following criteria, as measured by dynamic X-ray and MRI
- Symptomatic adjacent segment syndrome: is diagnosed when clinical symptoms such as radicular pain or intermittent claudication worsen postoperatively and the causative lesion is confirmed to be the adjacent segment to the treated level (on MRI).
- Surgical adjacent syndrome: is defined as a symptomatic adjacent syndrome for which surgery is necessary to treat neurological deterioration at the adjacent degenerative segment.
Measured: At least 9 years after enrollment in the pivotal study
Reoperation rate
A reoperation is defined as a secondary procedure at the implant site for any reason (infectious or mechanical): revision, removal of the implant (explantation), fusion, the need for additional fixation, or any procedure involving any part of the device or one of its complications
Measured: At least 9 years after enrollment in the pivotal study
Implant migration
Migration is defined as the displacement of the entire implant relative to its initial position: Migration is considered to have occurred if there is a deviation of more than 3 mm from the baseline measurement. This measurement is based on the MRI results.
Measured: At least 9 years after enrollment in the pivotal study
Implant wear measurement
Measurement taken between the anterior tip of the wedge and the posterior vertebral wall based on MRI results
Measured: At least 9 years after enrollment in the pivotal study
Number of Participants with Recurrent Herniated Disc
A recurrence of a herniated disc is defined as the onset of a herniated disc confirmed by imaging or following surgery at the same instrumented level in a patient who has undergone surgery. This definition allows for the inclusion of all herniations (both symptomatic and asymptomatic).
Measured: From enrollment in the pivotal study through the long-term follow-up assessment (at least 9 years)
Number and Rate of Adverse Events and Serious Adverse Events
The number and rate of adverse events (AEs) and serious adverse events (SAEs) reported since the 3-year follow-up visit, classified by nature and by organ system
Measured: From the 3-year follow-up visit through the long-term follow-up assessment (at least 9 years after enrollment in the pivotal study)
Overall Sagittal Alignment
Overall sagittal alignment will be assessed using full-spine radiography (teleradiography or EOS) at long-term follow-up.
Measured: At least 9 years after enrollment in the pivotal study
Number of device malfunctions
The number of device malfunctions (DM) reported since the 3-year follow-up visit
Measured: From the 3-year follow-up visit through the long-term follow-up assessment (at least 9 years after enrollment in the pivotal study)
Complications
The rate of intraoperative and short- and long-term postoperative complications
Measured: From the index surgery through the long-term follow-up assessment (at least 9 years after enrollment in the pivotal study)
Lumbar Lordosis
Lumbar lordosis (LL) will be measured using full-spine radiography (teleradiography or EOS) at long-term follow-up.
Measured: At least 9 years after enrollment in the pivotal stud
Segmental Lordosis at the Treated Level
Segmental lordosis (LS) at the instrumented (treated) level will be measured using full-spine radiography (teleradiography or EOS) at long-term follow-up
Measured: At least 9 years after enrollment in the pivotal study
Pelvic Incidence
Pelvic incidence (PI) will be measured using full-spine radiography (teleradiography or EOS) at long-term follow-up
Measured: At least 9 years after enrollment in the pivotal study
Sacral Slope
Sacral slope (SS) will be measured using full-spine radiography (teleradiography or EOS) at long-term follow-up
Measured: At least 9 years after enrollment in the pivotal study
Pelvic Version
Pelvic version (PV) will be measured using full-spine radiography (teleradiography or EOS) at long-term follow-up.
Measured: At least 9 years after enrollment in the pivotal study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start28 Jul 2020
- Primary completion1 Jun 2026
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back Pain of Disc OriginStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cousin Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790328
- Sponsor's protocol ID
- RC-P-T3-39
- Acronym
- IntraLT
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No