VAST Clinical Trial: Safely Supplementing Tissue Lost to Degenerative Disc Disease

Abstract

Background: The function of the intervertebral disc is structural. Loss of tissue alters biomechanics, leads to subsequent disc degeneration, and is attributable to discogenic pain. A viable structural allograft was delivered into degenerate discs to determine whether intervention could safely stabilize anatomy, reduce pain, and improve function.Methods: Following institutional review board approval and patient consent, subjects were randomized to receive allograft or saline at either 1 or 2 levels or continue nonsurgical management (NSM). Data were collected at baseline, 3, 6, and 12 months. Back pain with a visual analog scale (VAS) and disability by the Oswestry Disability Index (ODI) were assessed, as were adverse events. This trial is registered on http://www.clinicaltrials.gov (NCT03709901).Results: At 6 and 12 months, the VAS improved from 54.81, 55.25, and 62.255 in the allograft, saline, and NSM subjects, respectively, to 16.0 and 41.0 in the allograft and saline groups at 6 months, and 12.27 and 19.67, respectively, at 12 months. All subjects in the NSM cohort crossed over to allograft treatment. At 6 and 12 months, ODI improved from 53.73, 49.25, and 55.75 in the allograft, saline, and NSM subjects, respectively, to 18.47 and 28.75 in the allograft and saline groups 1 and 2 at 6 months, and 15.67 and 9.33, respectively, at 12 months. At 3 months the ODI of the NSM group was 62.75 and subjects reached 19.0 and 11.0 at 6 and 12 months, respectively. Adverse events were transient and resolved in all cohorts.Conclusions: This study is supported by data demonstrating that improved pain and function at 12 months can be attained with a supplemental viable disc matrix. Subjects receiving the VIA Disc Matrix achieved improvements that were durable at 12 months.Level of Evidence: 1. Clinical Relevance: Initial assessments indicate that a 1-level or 2-level treatment offers a reliable intervention that is safe and beneficial. Biologics Keywords: disc degeneration, viable disc matrix, supplemental disc allograft, back pain 52. Boden SD, Davis DO, Dina TS, Patronas NJ, Wiesel SW. Abnormal magnetic-resonance scans of the lumbar spine in asymptomatic subjects. J Bone Joint Surg Am. 1990;72A;403-408. 53. Brinjikji W, Luetmer PH, Comstock B, et al. Systematic literature review of imaging features of spinal degeneration in asymptomatic populations. AJNR Am J Neuroradiol.

Morphological Analysis of the Human Lumbar Spine Using Sagittal Magnetic Resonance Imaging

“…For example, O, P, and Q measured from the AMR sample were not significantly different from those measured from the ASYM sample. Spinal intervertebral discs 3 consists of highly hydrated soft tissue structures (i.e., nucleus pulposus), which provide mechanical properties to support spinal movement and bear spinal loadings (Beall, et al, 2020). A degenerated nucleus pulposus is an unorganized, less hydrated soft tissue with substantially less capability to bear loads, which may result in decreased disc height and intradiscal space (Vergroesen, et al, 2015).…”

Treatment of Degenerated Intervertebral Discs using a Viable Disc Tissue Allograft for Chronic Discogenic Low Back Pain: A Randomized Controlled Trial Comparing Single-Site Outcomes with Aggregate and Longer-term Follow-Up Data

“…30,31 The VAST trial was the rst, and largest randomized clinical study to measure the safety and e cacy of viable disc tissue allograft supplementation in the treatment of painful lumbar degenerative disc disease. 15,16 At 12month follow up, this RCT suggests that viable disc tissue allograft may be a bene cial nonsurgical treatment for patients that have chronically painful lumbar degenerative discs. Subjects treated with viable disc tissue allograft exhibited minimal clinically important difference (MCID) improvements in both functional and pain outcomes based on accepted indices for 15-point improvement of ODI, or 30% reduction in pain assessed by VAS.…”

“…Two hundred eighteen patients were enrolled in the trial across 13 sites and were followed from August 2017 to March 2020. 15,16 Adult patients were included if they had 1 or 2 moderately degenerated lumbar intervertebral discs and had lower back symptoms present longer than 6 months that had not responded to nonoperative care. Radiographs, magnetic resonance imaging (modi ed-P rrmann disc degeneration grades 3 through 6), and physical examination were used to identify painful discs.…”

“…A multicenter prospective trial, the Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients with Low Back Pain With or Without Disc Herniation (VAST) trial, provided no evidence that patients treated at sites with greater enrollment derived different therapeutic bene ts. 15,16 To assess the durability of the viable disc allograft supplementation, a single site was selected to evaluate 24-and 36-month follow-up visits of the subjects initially enrolled in the VAST study. We compared the single-site outcomes to the overall study outcomes at these longer follow-up visits.…”

Is Saline Injection a True Sham/Placebo Treatment in Randomized Controlled Trials? A Systematic Review

“…In a recent prospective, multicenter RCT, Beall and collaborators analysed the results of 220 patients with discogenic pain due to disc degeneration using MRI scoring, physical examination and pain evaluation [9]. Patients were randomized to receive intradiscal active allograft, non-surgical management (NSM) or saline as a placebo.…”