UNPARALLELED
Level l Clinical Evidence
The Intracept Procedure is supported by two Level l randomized clinical trials. Intracept has demonstrated statistical significance compared to both standard care and sham, durable results at 2 years, and consistent improvement in both pain and function across both trials.
Level I
SMART Trial 1
Long-term Relief Beyond 5 Years 2, 3
Level I
INTRACEPT Study
Demonstrated Clinical Significance 4
Consistent Outcomes in Two Level I Trials 1, 4
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. https://doi.org/10.1007/s00586-020-06448-x
4. Khalil J, Smuck M, Koreckij T, et al. A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain, The Spine Journal (2019). doi: https://doi.org/10.1016/j.spinee.2019.05.598