| Eligibility |
Inclusion Criteria:
- Male or female subjects aged 22 to 85 years, inclusive
- Subjects presenting with LBP greater than leg pain and symptoms of DDD of the lumbar
region (L1- S1) of at least six (6) months duration
- Presence of one (1) or two (2) symptomatic disc(s) (i.e., only 1-level or 2-levels may
be treated during the study) as determined by Discography
- Symptomatic disc(s) exhibiting Grade 4 to 8 degeneration on the modified Pfirrmann
scale as determined by MRI
- Failure to have their symptoms resolve or reduce following at least six (6) months of
conservative care (as defined in the body of the protocol)
- Psychosocially, mentally and physically able and willing to fully comply with this
protocol including adhering to follow-up schedule and requirements and filling out
forms
- English fluency
- Signed informed consent
Exclusion Criteria:
- History of or active systemic or local infection
- Any skin disease or inadequate tissue coverage at the site of the proposed injection
- Annular tear or defect that shows free contrast extravasation into the epidural space
during or after Discography
- Presence of more than two (2) symptomatic discs presenting with pain confirmed during
Discography
- Presence of extruded or sequestered disc herniation (i.e., disc extrusions or
sequestrations) at the symptomatic level(s) or on adjacent levels
- Presence of wide annular fissures confluent with large disc protrusions at the
symptomatic level(s)
- Epidural steroid injection, intradiscal injection, trigger point injection, facet or
medial branch block within 60 days of enrollment
- Opioid medication usage >60 MME (morphine milligram equivalent)/day or increase in
opioid use within 60 days of enrollment
- Evidence of Modic type 3 changes
- Subjects presenting with radicular pain greater than back pain or by history within
the past six (6) months. Radicular pain is defined as nerve pain following a
dermatomal distribution and that correlates with nerve compression on imaging. Note:
somatic referred pain is allowed
- Evidence of neurogenic claudication due to spinal stenosis
- Subjects with any prior back surgery on the lumbar spine
- History of vertebral fractures in the lumbar spine
- Evidence of severe compression of cauda equina
- Evidence of spinal segmental instability (spondylolysis or spondylolisthesis: Grade
>1), severe spinal canal stenosis, isthmus pathology, or scoliosis [Cobb angle >20 at
the index level(s)]
- Subjects with arachnoiditis
- Subjects who are prisoners or wards of courts
- Subjects involved in active litigation including worker's compensation cases
- Subjects on chronic anticoagulation due to a bleeding disorder and unable to safely
stop anticoagulants, or has taken anticoagulants within three (3) days prior to
procedure
- Subjects with LBP of non-spinal or unknown etiology
- Subjects who have a history (in the last five (5) years) of substance abuse or
chemical dependency (pharmaceuticals, illicit drugs, alcohol) or are current abusers
(using definition criteria from the Diagnostic and Statistical Manual of Mental
Disorders (DSM-V))
- Subjects who have major psychiatric disorders, such as major depression, bipolar
disorder and schizophrenia, as defined by the DSM-V
- If female, subjects 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 inability or unwillingness to adhere to the
study follow-up visit schedule or other protocol requirements
- Subjects having participated in any other clinical study within the last three (3)
months, or are actively participating in any other clinical study, or have planned
participation in any other clinical study during the course of this trial. Note:
subjects must agree they will not participate in any other clinical study during the
course of this trial
- Body Mass Index (BMI) >35 kg/m2
- Current smoker or nicotine and/or tobacco user
- Known allergy or hypersensitivity to any of the device materials
- Endocrine or metabolic disorder known to affect osteogenesis
- Insulin-dependent diabetes mellitus
- Inability to undergo X-ray, MRI, CT scans or other radiographic assessments, including
Discography
- Any comorbid medical condition which, in the best judgement of the Investigator, would
make the subject unsuitable for inclusion in the study or interferes with the proper
assessment of safety or effectiveness (e.g., systemic disease)
- Subjects with any active malignancy or who have been previously diagnosed with a
malignancy and have evidence of residual disease
- Any degenerative or neurological condition that would interfere with evaluation of
outcomes or that may generate an unacceptable risk of failure or postoperative
complications
- Chronic or acute renal and/ or hepatic impairment
- Evidence of severe osteoporosis. The FRAX will be utilized to screen if a DEXA scan is
indicated. If the subject's 10-year probability of any major osteoporotic fracture
according to FRAX is at least 20% or a hip fracture risk of 3% or more, then a DEXA
scan is required. Severe osteoporosis is defined by the threshold of bone density
value below the -2.5 SDs of T-score, determined by DEXA, and the presence of one or
more fragility fractures
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