Joint Facet Syndrome, Lower Back Pain of Disc Origin, Lumbar Canal Stenosis, Spinal Disease
Conditions
Brief 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. Approximately 50 patients have been included to date and their long terms results (at least 9 years) will be assessed.
Interventions
DRUGIntraSPINE
Intraspine is an interlaminar device not interspinous.
Sponsors
Cousin Biotech
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success rate at long term (at least 9 years) | At least 9 years after enrollment in the pivotal study | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radicular and low back pain | At least 9 years after enrollment in the pivotal study | 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. |
| Walking time | At least 9 years after enrollment in the pivotal study | Walking time will be estimated by measuring the time it takes to cover the maximum possible distance |
| Finger-to-floor test | At least 9 years after enrollment in the pivotal study | 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 |
| Disc height (anterior and posterior) | At least 9 years after enrollment in the pivotal study | Disc height (anterior and posterior) will be measured based on the MRI results |
| Mobility of the highest treated level and the adjacent level | At least 9 years after enrollment in the pivotal study | 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. |
| Pfirmann and Modic classification | At least 9 years after enrollment in the pivotal study | The Pfirmann and Modic classification (affected level and adjacent level) based on MRI results |
| Patient satisfaction | At least 9 years after enrollment in the pivotal study | 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) |
| Number of Participants with Adjacent Syndrome | At least 9 years after enrollment in the pivotal study | 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. |
| Reoperation rate | At least 9 years after enrollment in the pivotal study | 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 |
| Implant migration | At least 9 years after enrollment in the pivotal study | 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. |
| Implant wear measurement | At least 9 years after enrollment in the pivotal study | Measurement taken between the anterior tip of the wedge and the posterior vertebral wall based on MRI results |
| Number of Participants with Recurrent Herniated Disc | From enrollment in the pivotal study through the long-term follow-up assessment (at least 9 years) | 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). |
| Number and Rate of Adverse Events and Serious Adverse Events | From the 3-year follow-up visit through the long-term follow-up assessment (at least 9 years after enrollment in the pivotal study) | 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 |
| Overall Sagittal Alignment | At least 9 years after enrollment in the pivotal study | Overall sagittal alignment will be assessed using full-spine radiography (teleradiography or EOS) at long-term follow-up. |
| Number of device malfunctions | From the 3-year follow-up visit through the long-term follow-up assessment (at least 9 years after enrollment in the pivotal study) | The number of device malfunctions (DM) reported since the 3-year follow-up visit |
| Complications | From the index surgery through the long-term follow-up assessment (at least 9 years after enrollment in the pivotal study) | The rate of intraoperative and short- and long-term postoperative complications |
| Lumbar Lordosis | At least 9 years after enrollment in the pivotal stud | Lumbar lordosis (LL) will be measured using full-spine radiography (teleradiography or EOS) at long-term follow-up. |
| Segmental Lordosis at the Treated Level | At least 9 years after enrollment in the pivotal study | Segmental lordosis (LS) at the instrumented (treated) level will be measured using full-spine radiography (teleradiography or EOS) at long-term follow-up |
| Pelvic Incidence | At least 9 years after enrollment in the pivotal study | Pelvic incidence (PI) will be measured using full-spine radiography (teleradiography or EOS) at long-term follow-up |
| Sacral Slope | At least 9 years after enrollment in the pivotal study | Sacral slope (SS) will be measured using full-spine radiography (teleradiography or EOS) at long-term follow-up |
| Degree of functional disability | At least 9 years after enrollment in the pivotal study | 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. |
| Pelvic Version | At least 9 years after enrollment in the pivotal study | Pelvic version (PV) will be measured using full-spine radiography (teleradiography or EOS) at long-term follow-up. |
Countries
France
Outcome results
None listed