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.
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
Allergy to any of the components,
Infected site,
Pregnant women.
Patients with spondylolisthesis with isthmic lysis
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.
Cohort
Prospective
IntraSPINE
DrugIntraspine is an interlaminar device not interspinous.
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
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.
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.
Walking time
Walking time will be estimated by measuring the time it takes to cover the maximum possible distance
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
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