Long-Term Evaluation of the Performance and Safety of the IntraSPINE® Interlaminar Implant in the Treatment of Lumbar Degenerative Disc Disease

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

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.

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 will be estimated by measuring the time it takes to cover the maximum possible distance

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) will be measured based on the MRI results

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.

The Pfirmann and Modic classification (affected level and adjacent level) based on MRI results

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)

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.

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

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.

Measurement taken between the anterior tip of the wedge and the posterior vertebral wall based on MRI results

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).

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 will be assessed using full-spine radiography (teleradiography or EOS) at long-term follow-up.

The number of device malfunctions (DM) reported since the 3-year follow-up visit

The rate of intraoperative and short- and long-term postoperative complications

Lumbar lordosis (LL) will be measured using full-spine radiography (teleradiography or EOS) at long-term follow-up.

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 (PI) will be measured using full-spine radiography (teleradiography or EOS) at long-term follow-up

Sacral slope (SS) will be measured using full-spine radiography (teleradiography or EOS) at long-term follow-up

Pelvic version (PV) will be measured using full-spine radiography (teleradiography or EOS) at long-term follow-up.