Level 1 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 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 CLBP exhibited significantly greater improvement in ODI at 3 months and a higher response rate than did the sham-treated controls. Intracept represents a minimally invasive treatment option for the relief of chronic low back pain.