Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence

Exclusion Criteria

• •Spondylolisthesis and/or instability at the index level that, in the judgement of the surgeon, could affect the device implantation.
• •Central, foraminal or extraforaminal disc hernia.
• •Subject has vertebral bodies of the index level affected by any traumatic, neoplastic, metabolic, or infectious pathology.
• •Subject has scoliosis of greater than 20 degrees (both angular and rotational).
• •Grossly distorted anatomy due to congenital abnormalities.
• •Deformation that affects the posterior corners of the vertebra at the index level (e.g., osteophytes) that, in the judgment of the surgeon, could affect the device implantation.
• •Endplate irregularities that, in the judgment of the surgeon, could affect the device implantation.
• •Prior surgery at the index lumbar vertebral level that, in the judgment of the surgeon, could affect the device implantation.
• •Radiological confirmation of severe facet joint disease or degeneration.
• •Patients diagnosed or at a high risk of osteoporosis (such as postmenopausal women and patients receiving long-term treatment with corticosteroids) who present a bone densitometry DXA (dual energy x-ray absorptiometry) T-score of less than -2.0 at the index level.
• •Cauda equina syndrome.
• •Fever, leucocytosis and/or systemic or localized active infection.
• •Systemic inflammation and/or inflammation at the implantation site.
• •Any uncontrolled metabolic bone disease that affects the spine.
• •Uncontrolled insulin-dependent diabetes mellitus.
• •Peripheral neuropathy.
• •Active hepatitis, AIDS or HIV.
• •Rheumatoid arthritis or other autoimmune disease that affects the spine joints.
• •Active or history of any invasive malignancy; patients with curatively-treated malignancies who have been disease-free for at least 5 years are eligible.
• •Uncontrolled active tuberculosis or history of uncontrolled tuberculosis in the past 3 years.
• •Immunologically suppressed patients.
• •Current anticoagulation therapy, unless anticoagulation therapy can be suspended for surgery.
• •Patients who have received medication (e.g., methotrexate, alendronate) that interferes with bone mineral metabolism within 4 weeks of the planned date of the index surgery.
• •Suspected or known allergies or intolerance to the device materials: titanium, nitinol, stainless steel, polyetheretherketone and polyethylene terephthalate.
• •Any condition that precludes the use of general anaesthesia.
• •Any condition that precludes the surgical procedure.
• •Any contraindication for MRI or CT scan.
• •Class III obesity: Body mass index ≥ 40.
• •Current alcohol or recreational drug dependency.
• •Pregnant or interested in becoming pregnant in the following 24 months.
• •Breastfeeding.
• •Life expectancy less than 2 years.
• •Subject is currently participating or has participated in the previous 4 weeks in any other interventional clinical study.