Relievant Medsystems has announced the publication of long-term data from the Level I SMART trial showing durability of improvements in pain and function beyond five years for patients treated for chronic low back pain with the Intracept procedure. The data were published in the European Spine Journal.
The long-term study is a single-arm, open-label, prospective follow-up of 100 patients in the USA (85% retention) who were successfully treated with basivertebral nerve ablation in the SMART randomised study. Mean patient follow-up was 6.4 years post-procedure (range: 5.4‒7.8 years). The study evaluated functional impact using the Oswestry Disability Index (ODI), low back pain scores using a Visual Analogue Scale (VAS), pain interventions post-BVN ablation, and patient satisfaction.
Significant differences were demonstrated at a minimum of five years post-procedure, including the following:
- Mean reduction in ODI of 25.95 to 16.86 from a baseline of 42.81 (p<0.001); nearly twice the minimal clinically important difference of 15
- Mean reduction in VAS of 4.38 to 2.36 from a baseline of 6.74 (p<0.001); twice the minimal clinically important difference of 2
- Nearly half of patients (47%) reported 75% or greater reduction in pain; more than a third (34%) reported complete pain resolution
- 75% of patients demonstrated both a >15-point ODI improvement and >2-point VAS improvement
- 73% reduction in active opioid use, defined as taking an opioid at least once per week
- 93% reduction in injections compared to baseline
- High patient satisfaction with the procedure
- 79% indicated they would have the procedure again for the same condition
- 65% had resumed the level of activity they enjoyed prior to low back pain
“The improvements in pain and function sustained for more than five years following the Intracept procedure are truly remarkable,” said Jeffrey Fischgrund, Chairman, Orthopedics, Beaumont Hospital (Royal Oak, USA) and the principal investigator of the study. “Very few high-level studies have published such long-term results for this patient population—the magnitude and durability of improvement raises the standard for the treatment of chronic low back pain.”
“Following publication of two Level I Randomised Control Trials, the SMART study and the INTRACEPT study, we are pleased to see such a meaningful degree of clinical improvement being maintained more than five years after patients received the Intracept procedure,” said Art Taylor, president and CEO of Relievant Medsystems. “This unparalleled level of clinical evidence demonstrating that Intracept is a highly-effective and durable therapy with a very favourable safety profile, is strongly compelling for physicians, payers, and most of all, patients suffering from vertebrogenic chronic low back pain.”