VIA Disc NP is a non-surgical intervention intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs.
The study will include adult subjects, ages 65 years and older, with symptomatic lumbar intervertebral disc degeneration that is not adequately resolved by non-surgical standard care. Each subject will receive one injection per each affected level (max of 3 levels) and be evaluated for efficacy and safety during the 6 month observation period. The study is expected to be completed within 18 months, inclusive of enrollment and follow-up for all subjects. Subjects will be evaluated at baseline and followed through 6 months to establish safety and efficacy of the treatment. The expected duration of subject participation from screening/enrollment through final follow-up is 26 weeks
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
A single dose, intradiscal injection of 100mg of VIA Disc NP mixed with 2ml sterile saline administered to the affected 1 to 3 levels, L1-S1.
Florida Spine & Pain Specialists
Tampa, Florida, United States
Southern Pain and Spine Associates
Newnan, Georgia, United States
Paradigm Spine Care & Interventional Pain
Slidell, Louisiana, United States
Center for Clinical Research
Winston-Salem, North Carolina, United States
Patient self-reporting of Functional Efficacy with no change in neurological status using the Oswestry Disability Index (ODI)
Evaluate the change from baseline in functional disability on the Oswestry Disability Index (ODI) measured from 0 (minimal disability) to 100 (maximal disability). The ODI is 10 categories of function to quantify disability due to low back pain.
Time frame: baseline to 3 months
Review of all Adverse Events for Safety of treatment and product
Evaluate the incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events from baseline through the final follow-up visit that are related to treatment and product
Time frame: baseline to 6 months
Patient self-reporting of Pain
Changes in Numeric Rating Scale (NRS) scores. Eleven point pain scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable). Analysis at 3 months measuring subjects meeting lower back pain NRS improvement.
Time frame: baseline and 3 months
Patient self-reporting of Function
Oswestry Disability Index (ODI) is measured 0 (minimal disability) to 100 (maximal disability). This index is comprised of ten categories of function to quantify disability due to low back pain. Functional responder analysis at 3 and 6 months measured as subjects meeting functional improvement of ≥ 10, 15 and 20 points in ODI scores.
Time frame: 3-6 months
Patient self-reporting of Pain
Changes in Numeric Rating Scale (NRS) scores. Eleven point pain scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable). Analysis at 3 and 6 months measured as subjects meeting lower back pain NRS improvement of 50%.
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Precision Spine Care
Tyler, Texas, United States
Time frame: 3-6 months
Patient self-reporting of Pain in low back
Changes in Numeric Rating Scale (NRS) scores. Eleven-point pain scale used for patient to self-report level of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable). Analysis at 3 and 6 months measured as subjects meeting lower back pain NRS improvement of ≥30%.
Time frame: 3-6 months
Oswestry Disability Index (ODI) score change
Change from baseline in ODI scores at 6 months. Ten category index comprising of function to quantify due to low back pain. ODI is measured 0 (minimal disability) to 100 (maximal disability).
Time frame: baseline and 6 months
Numeric Rating Scale change
Changes from baseline in Numeric Rating Scale (NRS) score at 6 months. Eleven-point pain scale used for patient self-reporting of pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable).
Time frame: baseline, and 6 months
Neurological status change
Change from baseline in motor function (graded 0 - no movement to 4 - active movement against resistance), reflexes (0 - absence to 4 - abnormal/hyperactive) and sensory status (graded normal or abnormal) based on physician's physical exam at 1, 3, and 6 months.
Time frame: baseline, 1, 3 and 6 months
Magnetic Resonance Imaging (MRI) review to determine disc health changes
Magnetic Resonance Imaging (MRI) taken at baseline compared to 6 months reviewing changes in treated disc levels (disc height, volume hydration of disc and Modified Pfirrman grade)
Time frame: baseline - 6 months
Morphine Milligram Equivalents (MME) change
Changes from baseline in morphine milligram equivalents use at 3 and 6 months.
Time frame: baseline, 1, 3 and 6 months
PROMIS-29 change
Change from baseline in pain intensity at 3 and 6 months. Questionnaire with 29 questions using a since 0-10 numeric rating item and sevel health domains (physical function, pain interference, fatigue depressive symptoms, anxiety, ability to participate in activities and sleep) utilizing four questions per domain.
Time frame: baseline, 3 and 6 months