Relievant Medsystems recently announced the publication of the Level I INTRACEPT Study results in The Spine Journal. The INTRACEPT Study is a Level I, randomised, multicentre trial comparing the Intracept Procedure to non-surgical standard care. Based on the results of a prespecified interim analysis, the independent Data Management Committee recommended investigators stop study enrolment early and cross-over the control arm patients due to clinically and statistically superior outcomes in patients treated with the Intracept Procedure.
The interim analysis included 104 patients, 51 in the Intracept arm and 53 in the standard care arm, enrolled at 20 sites in the USA. The published results demonstrated a highly significant difference between the Intracept arm and the standard care arm for the primary endpoint and all secondary endpoints. Key results from the study include:
- Intracept treated patients demonstrated a 20.9 point greater improvement in Oswestry Disability Index (ODI) compared to standard care (p<0.001) for the primary endpoint of mean reduction from baseline to three months
- The mean Visual Analog Scale (VAS) for low back pain was also reduced by 2.44 cm more in the Intracept treatment arm as compared to the standard care arm (p<0.001)
- 74.5% of patients in the Intracept arm reported a minimal clinically important difference of ≥10-point ODI reduction and 62.7% reported a ≥20-point ODI reduction at three months, both highly significant compared to standard care (p<0.001)
- Twice the number of patients in the Intracept arm reached a minimal clinically important difference of ≥2 cm reduction in VAS at 72.5% compared to 34.0% of patients in the standard care arm (p<0.001)
- There were no serious device or device-procedure related events reported
“Patients with chronic low back pain have limited options beyond standard conservative care. These results confirm that the Intracept Procedure is a highly effective new treatment option for these patients,” said Jad Khalil, orthopaedic spine surgeon, William Beaumont Hospital, Royal Oak, USA. “The outcomes of the INTRACEPT Study build upon the Level I SMART Trial results. Collectively, there are now two large, high-quality randomised control trials demonstrating the effectiveness of this treatment for patients with chronic vertebrogenic low back pain and Modic Type 1 or 2 changes.”
“The INTRACEPT Study results provide compelling data comparing the Intracept Procedure to currently available, real-world treatment options,” said Kevin Hykes, CEO of Relievant Medsystems. “These results complement the recently published 24-month results from the Level I SMART Trial and provide an unparalleled body of Level I evidence supporting the effectiveness and durability of the Intracept Procedure.”
