Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy (LOPAIN1)

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Degenerative Disc Disease, DDD, Chronic Low-back Pain, Disc Herniation, Nucleus Replacement, Low back pain Read More

Inclusion Criteria:

• Patient is skeletally mature and between 21 and 60 years of age.
• Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1
• History and clinical findings suggestive of symptomatic DDD:

Darkened disc on MRI in T2 weighted images Patients with at least 6 months of low back pain (location defined as the space between the lower margin of the posterior rib cage and horizontal gluteal fold) that is resistant to nonsurgical conservative therapy.

• Patient has adequate disc height (~6mm) at the level to be treated
• Patient has pre-operative Oswestry Low Back Disability score of greater than or equal to 40 (0-100 scale).
• Patient has pre-operative back pain VAS score of greater than or equal to 40 (0-100 scale)
• Patient has received conservative, non-surgical treatment for back pain for a minimum of 6 months.
• Patient has signed the approved Informed Consent Form.

Exclusion Criteria:

• Patient has had prior lumbar spine surgery
• Spinal fusion at any level
• Patient has ankylosing spondylitis or other spondyloarthropathy.
• Patient has isthmic spondylolisthesis or degenerative spondylolisthesis greater than 2 mm.
• Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.
• Patient has significant facet disease.
• Patient has had prior lumbar spine surgery
• Spinal fusion at any level
• Patient has any known active malignancy.
• Patient has previously undergone or currently on immunosuppressive therapy. Steroids used to treat inflammation are allowed.
• Patient has active local or systemic infection.
• Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease, including AIDS, ARC and HIV.
• Patient has diabetes mellitus (Type 1 or 2), requiring daily insulin management.
• Patient is pregnant or plans to become pregnant during the course of the study. Pregnancy ruled out by urine or serum HCG.
• Patient has a known allergy to silicone (polymer and balloon material) or barium sulfate (polymer).
• Patient participated in another investigational drug or device study within the past 30 days.
• Patient belongs to a vulnerable population or has a condition such that his/her ability to provide informed consent, comply with follow-up requirements, or provide self- assessments is compromised (e.g. developmentally disabled, prisoner, chronic alcohol/ substance abuser)
• Patient has a significant disc herniation at the level to be treated
• Patient has a significant Schmorl's node in the level to be treated

Intraoperative exclusion criteria:

• Protrusion of the 20A imaging balloon up to or beyond the outer margin of the vertebra during the imaging steps.
• Patient has a violated endplate as determined by imaging balloon during fluoroscopy
• Patient has a disc space that is too narrow for implantation.