Intraosseous Basivertebral Nerve Ablation – Pooled 5-Year Outcomes from Three Clinical Trials

Report long-term effectiveness and safety outcomes of BVNA from three clinical trials.


Materials and Methods:

Five-year post-BVNA outcomes from patients treated with BVNA were pooled across three prospective studies: 1) SMART RCT (BVNA versus sham control); 2) INTRACEPT RCT (BVNA versus standard care); and 3) single-arm study of BVNA. The primary outcome for the pooled analysis is change in Oswestry Disability Index (ODI) at 5-years compared to baseline; as observed, last observation carried forward (LOCF) and intent to treat (ITT) analyses were completed. Secondary outcomes include visual analog scale (VAS)/numeric pain score (NPS), opioid medications, pain interventions/surgeries, patient satisfaction, and safety. At baseline, the mean age was 48.5 years (range 26 to 71 years); 47.8% were female, and 71.9% reported LBP for ≥ 5 years. The most common vertebral levels treated were L5 (98% of patients) and S1 (71% of patients).



Results:

Two-hundred and forty-nine (N=249) of 320 patients with vertebrogenic pain received BVNA and completed 5-year follow-up visits (78% participation rate).  Pain and functional improvements were clinically and statistically significant at 5-years with a mean improvement in NPS of 4.32 ± 2.45 points (95% CI 4.01, 4.63; p< 0.0001) and in ODI of 28.0 ± 17.5 (95% CI 25.8, 30.2; p< 0.0001), as observed. LOCF and ITT analyses for ODI also demonstrated significant improvements in function from baseline to 5 years (see Table 1). Nearly one-third (32.1%) of patients reported being pain-free (NPS=0) at five years, 72.7% of patients indicated their condition improved and 68.7% had resumed activity levels they had prior to onset of CLBP. In the sixty-nine participants taking opioids at baseline, 65.2% were no longer taking them at 5-years, and spinal injections decreased by 58.1%. There were no serious device or device-procedure related adverse events reported during the long-term follow-up study.



Conclusion:

In this pooled cohort of patients with vertebrogenic low back pain, BVNA was shown to be safe, effective, and durable through 5 years post-BVNA. BVNA continues to be a viable treatment option for patients with clinical and radiographic evidence of vertebrogenic pain.