An observational study in Lower Back Pain of Disc Origin, Joint Facet Syndrome and Lumbar Canal Stenosis, sponsored by Cousin Biotech. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Cousin Biotech · Observational
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.
174 studies on the registry are indexed under Spinal Diseases; 39 are open to participants now.
This study's planned enrollment of 50 is below the median of 117 across 64 observational studies indexed under Spinal Diseases.
Browse Spinal Diseases studies →Cousin Biotech is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: IntraSPINE
Intraspine is an interlaminar device not interspinous.
Also known as: Interlaminar device
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
Time frame: At least 9 years after enrollment in the pivotal study
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: At least 9 years after enrollment in the pivotal study
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2020 to primary completion in Jun 2026, 70 months.
Of 32 observational studies under Spinal Diseases, half reached primary completion within 82 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 112. This study's 70 months is below that.
How these figures are worked out, and which studies are left out of them.
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