Using DISC Care to prevent recurrence of lumbar disc herniation

Inclusion Criteria:

* Subject is between 18 and 75 years old.
* Posterolateral disc hernia between levels L4 and S1 with radiological (CT scan or MRI) confirmation of neural compression.
* At least six weeks of failed conservative treatment prior to surgery, including physical therapy, use of anti-inflammatory medications at maximum specified dosage and/or administration of epidural/facet injections.
* Minimum posterior disc height of 5 mm at the index level.
* Radiculopathy with positive straight leg raise test.
* ODI score of at least 30/100.
* Subjects who are able to give voluntary informed consent to participate in the clinical investigation and from whom consent has been obtained.
* Subject is able and willing to comply with the protocol requirements.

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.