Patients with chronic discogenic back pain may find relief via viable disc allograft, according to the results of the VAST trial.
Featured Abstract 121, “Viable Disc Allograft Supplementation in Patients with Chronic Low Back Pain (VAST Trial): Interim 36-month Results of an Open-label Extension Study,” which will be presented by Islam Fayed, DO, details the 36-month results of a multi-site, randomized controlled trial to look at the efficacy and durability of ViaDisc, an allograft augmentation of the intervertebral disc for lower back pain caused by lumbar disc degeneration. Sponsored by VIVEX Biologics, the study included 218 patients with level 1 or 2 degenerative disease for allograft supplementation. The 12-month data was promising, and 50 patients were enrolled in a 35-month open-label extension. The abstract will be presented on Monday, March 6, 4:21 p.m., in Room 222c of the Phoenix Convention Center.
According to Douglas Beall, MD, FSIR, the lead author, his site participated in the extension due to that promising data. “The optimal response to ViaDisc at 1 year showed that patients experienced both improved both pain and function,” Dr. Beall said. “Up to 64% saw improvement in function and 65% saw improvement in pain.”
By enrolling in an extension, researchers were better able to see whether these improvements were maintained over time.
Of the 50 patients enrolled in the extension, 46 were treated with allograft supplementation and four received a saline placebo. Of the allograft group, 60% reported a more than 50% improvement in pain, and 70% saw substantial improvement in function.
Currently, traditional nonsurgical treatment for discogenic back pain has limited effectiveness and durability, researchers say. With the long-term data provided by the VAST trial, the researchers feel optimistic that allograft supplementation may turn the tide for viable patients with chronic lower back pain.
“This data is the largest long-term dataset for viable disc allograft therapy for chronic low back pain,” said Dr. Beall. “It showed durable pain relief and functional improvement through 3 years of follow-up. The initial benefits of the placebo (saline) diminished by 2 years, while patients retreated with ViaDisc had similar post treatment results to the patients who were initially treated at 12 months.”
More data is needed to confirm the safety and efficacy, Dr. Beall said, and there is already a follow-up phase III assessment of ViaDisc in the works which will compare allograft therapy to the standard treatments used in non-surgical management.
