Spinal Simplicity Announces New Real-World Fusion Study for Its Minuteman Device
Overland Park, KS, Aug. 30, 2023 – Spinal Simplicity announces publication of a new, prospective study that demonstrates clinically significant fusion rates in a real-world setting with patients who received the Minuteman device.
The Journal of Pain Research, the official journal of the American Society of Pain & Neuroscience, published the study, “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 prospectively evaluates fusion outcomes in patients receiving a Minuteman device for the treatment of degenerative spine diseases.
“This announcement today reflects what we’ve known all along: The Minuteman device fuses,” said CEO Todd Moseley. “Importantly, the allograft utilized for these cases was DBM, further demonstrating fusion resulted due to the fixation the Minuteman provides. This Real-World Study includes all comers, and no patients were excluded if they had comorbidities including cancer patients, diabetics, patients with prior surgery, and smokers.”
The study reflects 43 patients representing 69 total treated levels who received a CT scan at a mean of 459 days post-procedure. Fusion was assessed by three independent radiologists showing 93% of the assessed levels were fused.
There were also no instances of device migration, mechanical failures, or device related reoperations. The analysis from the radiologists demonstrated that Minuteman provides clinically meaningful fusion rates with a low risk of spinous process fracture or other device related complications.
“Thank you to Dr. Gabriel Jasper, Dr. Matthew Skoblar, Dr. Doug Beall and Dr. Tom Hedman for their significant contribution to this work. The purpose of this study was to evaluate lumbar spinal fusion outcomes in real-world patients instrumented with the Minuteman device,” said Adam Rogers, VP of Regulatory and Engineering. “We were able to show that patients receiving instrumented posterior arthrodesis of the lumbar spine using the Minuteman did indeed fuse at a rate comparable to other lumbar fusion constructs, and that the Minuteman performed very well mechanically with no intraoperative complications or device-related reoperations.”
View Journal of Pain Research Study: Skoblar M, Hedman T, Rogers AJ, Jasper GP, Beall DP. 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. J Pain Res. 2023;16:2909-2918
https://doi.org/10.2147/JPR.S417319