Long-Term Relief

5-Year Durability3


Purpose

Damaged or degenerated vertebral endplates are a significant cause of vertebrogenic chronic low back pain (CLBP). Modic changes on MRI are one objective biomarker for this type of low back pain. Prior data from the treatment arm of a sham-controlled, RCT showed maintenance of clinical improvements at 2 years following ablation of the basivertebral nerve (BVN). This study reports 5-year clinical outcomes.


Study Design

  • Prospective five year follow-up of the SMART US treatment arm patients 1, 2, 3
  • All 13 US treating sites participated
  • Retention rate of 85% per protocol treatment arm population (n=100) (PP = Per Protocol)
  • Mean follow-up of 6.4 years (range 5.4 to 7.8 years posttreatment)

Key Findings


Conclusion

CLBP patients treated with BVN ablation exhibit sustained clinical improvements in function and pain with high responder rates at a mean of 6.4 years following treatment. BVN ablation is a durable, minimally invasive treatment for vertebrogenic CLBP.

1. Fischgrund JS, Rhyne A, Franke J, Sasso R, Kitchel S, Bae H, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2018;27(5):1146-56. DOI: 10.1007/s00586-018-5496-1

2. Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results from a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study. International Journal of Spine Surgery, Vol. 13, No. 2, 2019, pp. 1–10. doi:10.14444/6015

3. Fischgrund JS, Rhyne A, Macadaeg K, Moore G, Kamrava E, Yeung C, et al. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5 year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. epub May 25, 2020.

*The intent-to-treat (ITT) population consisted of the patients as randomized and the per-protocol (PP) population excluded any patients in which the procedure could not be carried out, RF generated lesion did not colocate with BVN terminus or who were not compliant with the post-operative protocol.