Clinical Research Directory

Inclusion Criteria: * Patient is skeletally mature aged 22-70. * Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1 but the discogenic pain must be limited to a single level. * Patient has adequate disc height (6mm) at the level to be treated * Patient has exhausted a minimum of 6 months of conservative treatment for their back (e.g. physical therapy, medications, injections, life style changes, etc). * Patient has a preoperative Oswestry Disability questionnaire score ≥ 40 out of 100 points (40/100) * Patient has a low back pain Visual Analog Scale (VAS) ≥ 40 mm (4 cm) * Patient has signed the approved Informed Consent Form. * All surgeries must be approved by the Medical Advisory Board (MAB) Exclusion Criteria: * 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) 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 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.