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, consistent improvement in both pain and function across both trials, and durable results beyond five years post-procedure.
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.
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.
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.
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).