Level l SMART Trial

Demonstrates Durable Relief 1

Purpose

To evaluate the safety and effectiveness of radiofrequency (RF) ablation, in a Food and Drug Administration approved Investigational Device Exemption (IDE) trial, used to ablate the basivertebral nerve for the treatment of chronic low back pain (CLBP).

Study Design

  • Randomized, double-blind, sham-controlled
  • Multi-Center: 15 US and 3 EU sites
  • 225 Patients; Randomized to treatment (147) or sham (78) intervention
  • Patients were evaluated preoperatively and at 2 weeks and 6 weeks and 3, 6, 12 and 24 months postoperatively
  • Skeletally mature patients with chronic (≥ 6 months), isolated lumbar pain who had not responded to at least 6 months of non-operative management
  • All patients had Type 1 or Type 2 Modic changes of the treated vertebral bodies
  • Outcome Measures: ODI, SF-36, and VAS

  • Two pre-defined analysis populations in the study protocol*

Key Findings

ODI Score

Treatment Arm (Per Protocol Population)

In the Intracept treatment arm, patients reported a 23.6 point mean improvement in ODI, or a 54% decrease from their baseline score at 24 months.

VAS Score

Treatment Arm (Per Protocol Population)

In the Intracept treatment arm, patients reported a 3.6 point mean improvement in VAS, or a 53% decrease from their baseline score at 24 months.

Responder Rate

Treatment Arm (Per Protocol Population)

In the Intracept treatment arm, 76.4% of patients reported a 10 point or greater improvement in ODI, 57.5% of patients reported a 20 point or greater improvement in ODI, and 70.2% of patients reported a 1.5cm or greater improvement in VAS at 24 months.

Safety Results

There were no device or procedure related patient deaths, no unanticipated adverse device effects and no device related serious adverse events reported in the study. Imaging at 6 weeks and 6 months revealed no evidence of spinal cord abnormalities, avascular necrosis or accelerated disc degeneration.

Conclusion

Patients treated with Intracept for chronic vertebrogenic low back pain exhibited sustained clinical benefits in ODI and VAS and maintained high responder rates at 24 months following treatment. Intracept is a durable, minimally invasive treatment for the relief of chronic vertebrogenic low back pain.

1. 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

*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.