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.
Study Type
OBSERVATIONAL
Enrollment
50
Intraspine is an interlaminar device not interspinous.
Maison des consultations
Saran, France
RECRUITINGClinical 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
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