PT  - JOURNAL ARTICLE
AU  - BEALL, DOUGLAS P.
AU  - WILSON, GREGORY L.
AU  - BISHOP, RANDOLPH
AU  - TALLY, WILLIAM
TI  - VAST Clinical Trial: Safely Supplementing Tissue Lost to Degenerative Disc Disease
AID  - 10.14444/7033
DP  - 2020 Apr 01
TA  - International Journal of Spine Surgery
PG  - 239--253
VI  - 14
IP  - 2
4099  - https://www.ijssurgery.com/content/14/2/239.short
4100  - https://www.ijssurgery.com/content/14/2/239.full
SO  - Int J Spine Surg2020 Apr 01; 14
AB  - 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.