Study of the ReGelTec HYDRAFIL System

Exclusion Criteria

• •History of or current systemic or local infection
• •Annular tear or defect that shows free contrast extravasation into the epidural space during or after discography
• •Presence of disc herniation that accounts for the majority of the patient's symptoms
• •Subjects with Modic type 3 changes
• •Subjects with trans-endplate disc herniations or Schmorl's nodes
• •Neurogenic claudication due to spinal stenosis
• •Previous back surgery at the target level of the lumbar spine
• •Evidence of severe compression of cauda equina
• •Spinal segmental instability (spondylolysis or spondylolisthesis: Grade \>1), spinal canal stenosis, isthmus pathology, scoliosis \[Cobb angle \>20 at the incident level\] and other deformity conditions that may compromise the study
• •Subjects with arachnoiditis
• •Subjects who are prisoners or wards of the courts
• •Subjects involved in active litigation including worker's compensation cases
• •Subjects with low back pain of non-spinal or unknown etiology
• •Subjects with severe osteoporosis or metabolic bone disease
• •Subjects who have a history of or are current abusers of alcohol or drugs (using definition criteria from the Diagnostic and Statistical Manual of Mental Disorders (DSM-V))
• •If female, patients who are pregnant or are trying to become pregnant during the course of the trial. (due to risks of additional radiation exposures)
• •Failure to understand informed consent or participation in any other clinical study
• •Body Mass index (BMI) greater than 40
• •Patients with active tumors in the spinal region
• •Patients who have been diagnosed to diabetes mellitus
• •Patients who have a sensitivity or allergy to the implant materials