Initial results of a subset of the VAST Clinical Trial found that VIVEX Biologics, Inc.’s VIA Disc provided improvements in pain and disability scores up to 12 months after injection. The study, “VAST Clinical Trial: Safely Supplementing Tissue Lost to Degenerative Disc Disease” was published ahead of print in the International Journal of Spine Surgery in April 2020.
Early VIA Disc Results Indicate 12-month Pain Relief
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VIA Disc, a disc matrix allograft, was injected into the discs of patients suffering from degenerative disc disease (DDD) at up to two levels of affected disc space. A saline placebo and nonsurgical management groups were included as controls in the study “VAST Clinical Trial: Safely Supplementing Tissue Lost to Degenerative Disc Disease” published in the International Journal of Spine Surgery.
The study authors report reductions in visual analog scale (VAS) pain scores, and Oswestry Disability Index (ODI) scores through 12 months in patients receiving the treatment. Radiographic analysis also showed improvement in disc morphology and disc height suggesting potential improvements in disc health.
The 24-patient study safety cohort did not find statistically significant improvements and reported similar reductions in pain and disability in the saline control at 12-month follow-up. The rate of adverse events in the treatment group was elevated over the saline control, however, this was also not statistically significant due to the size of the study. The study authors point out that the loss of a placebo-controlled patient to follow-up resulted in the skewing of the small group’s recovery trajectory, possibly over emphasizing the improvements in pain and disability for the placebo group.
In a press release issued April 30, 2020, VIVEX CEO, Peter Wehrly said, “The early evidence from the VAST study suggests VIA Disc is able to deliver meaningful and durable pain relief, restore function and improve quality of life. We look forward to continuing to build this important clinical body of evidence.”
In regard to these early results the principal investigator of the study, and chief of radiology services at Clinical Radiology of Oklahoma, Douglas Beall, M.D. stated, “I am highly encouraged by the initial results and safety data from the VAST study. Implantation of disc tissue allograft can be done safely, and early evidence suggests greater than 70% improvements in VAS and ODI sustained at 12 months in the allograft groups.”
Whether the improvements reach statistical significance will be determined at the conclusion of the full study, which will include up to 220 enrolled patients at 15 clinical sites.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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