Viable Disc Allograft Supplementation in Patients With Chronic Low Back Pain (VAST Trial): Interim 36-month Results of an Open-label Extension Study

Monday, March 6, 2023

4:21 PM – 4:30 PM

Location: Phoenix Convention Center, 222C

Featured Presenter(s)

Islam Fayed, DO

Clinical Fellow
Clinical Radiology of Oklahoma

Disclosure information not submitted.

Author/Co-author(s)

Douglas Beall, MD

Chief of Radiology Services
Clinical Radiology of Oklahoma

Disclosure(s):

Islam Fayed, DO: No financial relationships to disclose

Purpose: Available treatment for discogenic back pain has limited effectiveness and durability. Previously reported at 12 months, clinical improvements in pain and function were achieved in both the investigational allograft and saline groups of the VAST randomized controlled trial. An open-label extension study is in progress. We report outcomes in patients who completed the 36-month follow-up.

Materials and Methods:

The study was conducted in 218 patients with 1or 2 level degenerative lumbar disc disease and refractory chronic low back pain. At 12 months, patients could continue in an open-label extension study for up to 36 months, with an interim visit at 24 months. In this interim analysis, we assessed mean change from baseline in VAS and ODI scores and categorical responder status. To minimize confounding, we compared these 36-month data with results from prior time points in this population only.

VIVEX Biologics, Inc. sponsored this study and contributed to study design, data monitoring, statistical analysis, and reporting of results and paid for independent data collection, core laboratory, and EDC services. All authors had complete access to data and were provided all analyses requested.

Results:

Nine of 12 sites participated in the extension; outcome data were entered for 50 patients at 36 months (allograft-treated, n=46; saline-treated, n=4). The 36-month completer population within each study arm was similar to the intent-to-treat population in age, sex, race, ethnicity, body mass index, and smoking status. In the allograft-treated group, change from baseline in VAS score (mean [95% CI]) at month 36 was -35.35 (± 25.39). Success rates in the allograft-treated group show that patients continued to have clinically meaningful benefits through 36 months in both pain and function, with 60% of patient reporting ≥ 50% improvement in pain and more than 70% of the patients had a ≥ 20 point reduction in ODI in VAS at 36 months.

Conclusion:

Patients treated with viable disc tissue allograft for degenerated lumbar discs showed sustained clinical benefits at 3 years following treatment. This interim analysis suggests that viable disc tissue allograft might be a durable, nonsurgical treatment for patients with chronically painful degenerated lumbar discs.