Randomized, Sham-Controlled, Multi-Center, Double-Blind Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft to Supplement Nucleus Pulposus Tissue in Participants With Lumbar Discogenic Pain Associated With Degenerative Disc Disease
VIA Disc NP is a non-surgical intervention intended to supplement nucleus pulposus tissue in degenerated intervertebral discs. This is a randomized, sham-controlled, multi-center, double-blind clinical trial with an open label roll-in period of one participant per site in which participants with lumbar discogenic pain associated with DDD will receive one VIA Disc NP treatment to each affected level (up to 2 levels). Participants enrolled after the roll-in stage will be randomized on a 2:1 basis to receive either a single VIA Disc NP intradiscal injection at 1 or 2 levels or the sham procedure at 1 or 2 levels. At 12 months, participants in the sham arm with continued symptoms may cross-over, receive VIA Disc NP, and will restart the study visit schedule, completing an additional 12 months of follow-up post-cross-over.
• Age 22 to 85 years old
• Diagnosis of moderate to severe DDD on MRI, Modified Pfirrmann Grade 3-7
• Chronic axial midline low-back pain in the absence of lower extremity motor/sensory/reflex changes with or without referred non-radicular leg pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care
• Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS
• ODI score of ≥ 40 to ≤ 80
• Positive sustained hip flexion test
• Demonstrated intolerance to sitting
• Able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
• Willing and able to comply with all study procedures and availability for the duration of the study with a life expectancy of \> 2 years