A Pilot Study Evaluating the Safety and Clinical Effectiveness of Nucleus Pulposus Allograft for Supplementation of Nucleus Pulposus Tissue in Older Patients With Symptomatic Degenerated Discs
VIA Disc NP is a non-surgical intervention intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs.
• Age 65 years or older
• Body mass index (BMI) ≤ 35
• Documented diagnosis of moderate radiographic degeneration of up to 3 intervertebral discs from L1 to S1, with a suspected associated discogenic chronic low back pain
• Chronic LBP for ≥ 6 months
• Discogenic low back pain diagnosis based on:
‣ History including low back pain aggravated with coughing, sneezing, and increase of abdominal pressure
⁃ Physical exam including pain with flexion (sitting or standing), and/or sitting intolerance
• Failed conservative care over the past 6 months of at least 2 conservative treatments including:
‣ oral pain medication (analgesics, steroids and/or non-steroidal anti-inflammatory drugs \[NSAIDs\]),
⁃ structured physical therapy or exercise program prescribed by physical therapist, chiropractor provider or physician specifically for the treatment of low back pain
⁃ epidural steroid injections and/or facet injections/selective nerve blocks
• An MRI demonstrating:
‣ 1 to 3 vertebral level involvement L1-S1
⁃ Modified Pfirrmann Grade 3-7
⁃ No Modic changes or if changes ≤ 2
• Oswestry Disability Index (ODI) score at time of evaluation of ≥ 21 and ≤ 80 points
• Low back pain of Baseline Numeric Rating Scale (NRS) score of ≥ 5 on the 11-point scale
• No signs or symptoms of current infection
• Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
• Be willing and able to comply with all study procedures and availability for the duration of the study with a life expectancy of \> 2 years