Relievant MedSystems has enrolled the first patient in its SMART trial (Surgical multicentre assessment of RF ablation for the treatment of vertebrogenic back pain). This level one, prospective, randomised, double-blind, sham-controlled clinical trial will evaluate the reduction of pain with the Intracept basivertebral nerve ablation procedure in patients with chronic axial low back pain.
The landmark SMART trial is enrolling 200 patients in up to 20 leading medical centres across the USA to determine the safety and effectiveness of the Intracept procedure. The primary endpoint is the evaluation of patient improvement in Oswestry Disability Index (ODI) at three months compared to baseline between treatment and sham populations. In addition, change in multiple patient-reported outcomes from baseline will be assessed at three, six, and twelve months as well as safety evaluations at all time points. Importantly, patients and clinicians who perform the follow-up evaluations are blinded to the randomisation of the sham vs. experimental procedure.
“The Relievant Intracept procedure is a potential breakthrough for the treatment of chronic low back pain, which addresses the unmet clinical need for patients who have failed traditional conservative treatment modalities,” said Jeffrey S Fischgrund, professor of Orthopaedic Surgery, Oakland University William Beaumont School of Medicine in Royal Oak, Michigan, USA, and the principal investigator of the trial. “I look forward to evaluating the Intracept procedure in the SMART trial which also has the opportunity of treating patients without the morbidity and expense of more invasive procedures.”
“The Intracept system brings important new capabilities to spine specialists to treat chronic low back pain. This revolutionary procedure and level one clinical study demonstrate our commitment to advancing patient care for millions of pain sufferers,” said CEO Alex DiNello. Relievant is also initiating a separate and similar level one study in Europe. Enrolment for both studies is expected to be completed in early 2013.