Spinal Simplicity Announces Publication of 2-Year Data From a Prospective Randomized Controlled Trial of Minuteman

A groundbreaking prospective randomized controlled trial (RCT) comparing the safety and efficacy of Minuteman, a minimally invasive interspinous fusion device, with standard open direct decompression for lumbar spinal stenosis, has yielded compelling results.

The study “24 Month Outcomes of Indirect Decompression using a Minimally Invasive Interspinous Fixation Device versus Standard Open Direct Decompression for Lumbar Spinal Stenosis: A Prospective Comparison,” sheds light on the potential benefits of Minuteman comparing to open decompression surgery.

Key findings from the study include:

  • Patients treated with the Minuteman device experienced significant improvements in various clinical parameters, including Visual Analog Scale (VAS) scores, Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ) scores, walking distance, and sitting to standing repetitions at both 12- and 24-months post-treatment. These outcomes were comparable to those observed in patients undergoing traditional surgical decompression.
  • Notably, 89% of the evaluated patients treated with the Minuteman device achieved successful fusion, indicating excellent long-term stability and efficacy of the minimally invasive approach.
  • Importantly, there were no device-related complications reported in either treatment group throughout the 24-month follow-up period. Additionally, there were no instances of reoperations required, highlighting the durability and safety of both treatment modalities.
  • Minuteman patients also benefited from reduced blood loss and operating room time compared to those undergoing standard open direct decompression, demonstrating the potential for decreased surgical morbidity and healthcare resource utilization associated with the minimally invasive approach.

These findings represent a significant advancement in the field of spinal surgery, offering patients and healthcare providers a viable alternative to traditional open surgery for lumbar spinal stenosis. By leveraging the advantages of minimally invasive techniques, such as reduced tissue trauma, faster recovery, and comparable clinical outcomes, the Minuteman device presents a promising option for improving patient care and surgical outcomes.

Dr. Timothy Deer, one of the study authors, commented, “The results of our study underscore the potential of the Minuteman device as a safe and effective treatment option for patients suffering from lumbar spinal stenosis. With its ability to achieve comparable clinical outcomes to traditional surgical decompression while offering advantages such as reduced blood loss and operating room time, this minimally invasive approach has the potential to revolutionize the management of this debilitating condition for the right patient.”

Todd Moseley, CEO of Spinal Simplicity, stated, “We are thrilled to see the positive outcomes of the Minuteman device in this clinical trial. These results validate our commitment to advancing minimally invasive spinal treatments and improving patient outcomes. We look forward to furthering our mission of innovation and excellence in spinal healthcare.”

Dr. Tom Hedman, one of the study authors, added, “The findings of this study reinforce the value of minimally invasive approaches in spinal surgery. By reducing procedural morbidity and optimizing patient outcomes, the Minuteman device offers a compelling option for both patients and healthcare providers.”

The findings of this RCT have been published in Journal of Pain Research and are now available for review. Click Here to Read Article in Journal of Pain Research