New gel implant offers hope for back pain sufferers

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Present with predominant low back pain and symptoms of DDD of the lumbar region of at least 6 months duration * Failure to have their symptoms resolve or reduce following 6 months conservative care (pain medication and/or physical therapy) * Male or female patients aged 22 to 80 years, inclusive * Presence of DDD on magnetic resonance imaging (MRI) scan with global disc degeneration. Modified Pfirrmann grades 5 to 8 as characterized by MRI * The presence of one or two symptomatic discs exhibiting degeneration contained within a competent outer annulus as determined by MRI and provocative discography and/or anaesthetic discography at L1-S1 * Patients who are legally competent and able to understand the nature, scope and aim of the clinical investigation * Signed an informed subject consent form in a language in which they are fluent 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