"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

Exclusion Criteria23

• Patient has less than 6 mm of disc height.
• Patient has had prior lumbar spine surgery (nucleoplasty at non-index level is considered acceptable).
• Patient has had spinal fusion in the lumbar or thoracic intervertebral spaces. Cervical fusion is allowed as long as there are no neurologic deficits in the lower extremities.
• Patient has spondyloarthropathy or other spondylolisthesis greater than 2 mm.
• Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.
• Patient has significant facet disease. Significant is defined as pain improvement of 80% or more following image-guided medial branch blocks of the target level according to SIS guidelines (diagnostic, contrast controlled).
• 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 or local 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 has osteopenia of the spine (T-score of -1.0 or lower). A DEXA scan should be performed to rule out patients considered at risk for osteopenia.
• Patient has morbid obesity defined as a body mass index (BMI) more than 40 or a weight of more than 45 kg (100 lbs.) over ideal body weight.
• Patient has a known allergy to silicone or barium sulfate.
• Patient has a significant disc herniation at the level to be treated. Significant is defined as a large, extruded herniation that creates a risk for expulsion.
• Patient has a significant Schmorl's node in the level to be treated. Significant is defined as a large, rectangular or irregular shaped node that has an associated active inflammatory process (Modic I changes).
• Patient has motion of less than 3 degrees on pre-operative lateral flexion/extension radiographs.
• 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)
• 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 balloons during fluoroscopy.
• Patient has a disc space that is too narrow for implantation. MIPL Specific
• Poor radiological visualization of Kambin's triangle.
• Sustained irritation of the exiting nerve root during any aspect of the annular dilation technique (leg movement or if performing with electrical monitoring) in spite or repositioning instruments.