VIA Disc NP is an allograft intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs.
The study will include adult subjects, ages 18 years or older, with symptomatic lumbar intervertebral disc degeneration that is not adequately resolved by non-surgical standard care. For the purpose of the primary analysis, subjects are considered enrolled in the study once they have signed the informed consent. Each subject will receive one injection per level (max of 2 levels) and be evaluated for efficacy and safety during the up to 24 month observation period. The study is expected to be completed within 26 months, inclusive of enrollment and follow-up for all subjects. Subjects will be evaluated at baseline and followed through up to 24 months to establish safety and efficacy of the treatment. The expected duration of subject participation from screening/enrollment through final follow-up is 104 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
VIA Disc NP is processed from donated cadaveric disc tissue, lyophilized, and micronized to particles.
California Orthopedics and Spine
Larkspur, California, United States
Source Health
Santa Monica, California, United States
IPM Medical Group
Walnut Creek, California, United States
Cleveland Clinic
Cleveland, Ohio, 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 Function
Owestry 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%.
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%.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinical Investigations, LLC
Edmond, Oklahoma, United States
Virginia iSpine
Richmond, Virginia, United States
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 3 and 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, 3 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 to 6 months
Return to work
Patient reported return to work - same or different capacity responses to employment questions will be assessed across time points and compared.
Time frame: baseline - 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, T1rho relaxation, T2 relaxation for up to 10 subjects)
Time frame: baseline-6 months