Level l SMART Trial

Demonstrates Statistically Significant Results

Purpose

To evaluate the safety and efficacy 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
  • 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
  • Primary Endpoint: Comparative change in Oswestry Disability Index (ODI) from baseline to 3 months

Key Findings

ODI Score

Treatment Arm (Per Protocol Population)

In the Intracept treatment arm, patients reported a 20.3 point mean improvement in ODI or a 48% decrease from their baseline score at 3 months. The improvement observed in the Intracept treatment arm was sustained through 12 and 24 months of follow-up.

Responder Rate

Treatment Arm (Per Protocol Population n=128)

In the Intracept treatment arm, 75% of patients reported a 10 point or greater improvement in ODI and 48% of patients reported a 20 point or greater improvement in ODI.

Primary End Point; Change in ODI

(Per Protocol Population n=205)

Mean ODI improvement observed in the Intracept treatment arm was statistically superior compared to the control arm (p = 0.019).

Safety Results

There were no device-related serious adverse events. The rates of transpedicular access-related events were low and comparable between arms, as were neurological events. 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 low back pain exhibited significantly greater improvement in ODI at 3 months and a higher response rate than the sham-treated controls in the Per Protocol Population. Intracept represents a minimally invasive treatment option for the relief of chronic low back pain.