Spinal Simplicity has a Banner Clinical Year Focusing on Research & Data for its Flagship Product, Minuteman®
Spinal Simplicity’s flagship Interspinous Fusion Device, Minuteman, has been the focus of three published studies this past year. These three groundbreaking studies resulted in showing Minuteman to be effective, safe with a high fusion rate, and comparing biomechanically to the gold standard of fusion – pedicle screws.
“Minuteman is not a new product, with surgeries starting in Europe in 2011 and the United States in 2015,” said Dr. Usman Latif, Department of Anesthesiology and Pain Medicine, University of Kansas Health System. “With the three studies published recently, Spinal Simplicity can now show with data and research that Minuteman is a safe procedure with high fusion rates. When I joined the prestigious group of authors including Dr. Tim Deer, I was excited to find with a multicenter study that the Minuteman procedure had high efficacy and an excellent safety record. This is a big win for patients who have failed conservative care for their chronic leg or back pain and who don’t want a larger surgery or are deemed non-surgical.”
Cureus: Minuteman Backing Up Lateral Interbody Cages
In July of 2023, Dr. Tom Hedman, Senior Principal Scientist at Spinal Simplicity, along with Dr. Donna Ohnmeiss, Jeremi Leasure, Oluwatodimu Raji and Dr. Stephen Hocschuler published: “Interspinous-Interbody Fusion via a Strictly Lateral Surgical Approach: A Biomechanical Stabilization Comparison to Constructs Requiring Both Lateral and Posterior Approaches.”
The goal of the study was to evaluate segmental multidirectional stability and maintenance of foraminal distraction of the Minuteman device compared to pedicle screw and facet screw constructs when combined with lumbar interbody cages in a cadaveric model. The authors analyzed multidirectional stability in cadaveric specimens. The results showed that Minuteman effectively stabilized the spine and maintained foraminal distraction when compared to pedicle and facet screw constructs. The authors concluded that Minuteman could be a favorable alternative to other posterior systems that require patient repositioning and involve greater disruption of native tissues.
Link to Publication: Minuteman Stabilization Comparison
Journal of Pain Research: Minuteman Prospective Study Evaluating Fusion Rates
In August of 2023, Drs. Gabriel Jasper and Matthew Skoblar of the Jasper Spine Institute, Dr. Doug Beall, Spinal Simplicity Senior Principal Scientist Dr. Tom Hedman, and Spinal Simplicity VP of Regulatory & Engineering Adam Rogers published, “Instrumented Posterior Arthrodesis of the Lumbar Spine: Prospective Study Evaluating Fusion Outcomes in Patients Receiving an Interspinous Fixation Device for the Treatment of Degenerative Spine Diseases.”
This study’s purpose was to assess fusion outcomes using CT scans of 43 patients who received instrumented posterior arthrodesis of the lumbar spine (Minuteman). 69 levels were evaluated at a mean of 459 days post-surgery. The fusion evaluation was performed by 3 independent radiologists. The results showed 92.8% of the assessed levels were considered fused, there were no interoperative spinous process fractures, and no instances of device mechanical failure or device related reoperation. The authors concluded that Minuteman provided clinically meaningful fusion rates with no reoperations and a low risk of spinous process fracture or other device related complications.
Link to Publication: Minuteman Fusion Rates
Journal of Pain Research: Minuteman Safety & Efficacy Study
Posterior Lateral Arthrodesis as a Treatment Option for Lumbar Spinal Stenosis: Safety and Early Clinical Outcomes was published in January of 2024. Drs. Anuj Shah, Jonathan Hagedorn, Usman Latif, Ashley Bailey-Classen, Nomen Azeem, Doug Beall, Pankaj Mehta, Chad Stephens, Larry Khoo and Tim Deer authored the study.
Procedure and patient safety were assessed during this multicenter (8 practices), retrospective analysis. Data collected included pre and post numeric rating scale score (pain assessment) and complication reporting. The results showed 191 patients, who were a mean age of 69.2 years old and BMI of 31.1, realized a 50.8% reduction in pain (p < 0.0001). There were no infections, no device migrations, or malfunctions. The authors concluded that Minuteman is a safe treatment option for patients with moderate Lumbar Spinal Stenosis who do not respond to conservative treatment.
Link to Publication: Minuteman Safety & Efficacy
“This research was nearly two decades in the making, dating back to 2011, and more is on the way,” said Dr. Chad Stephens of Fort Worth, TX. “Spinal Simplicity was able to publish in a 7-month time span three studies that reflect Minuteman as a safe, effective, and biomechanically solid construct. These conclusions and efforts are at the heart of why Spinal Simplicity’s founders, Neurosurgeon Dr. Harold Hess and CEO Todd Moseley, designed Minuteman: patient safety and excellent outcomes. These reasons are why I have implemented Minuteman as a safe option for my patients who have failed conservative care and have Chronic Degenerative Instability.”
For further information or media inquiries please contact Parker Snedden, Senior Director of Marketing, at psnedden@spinalsimplicity.com.