Evaluation of Functional Motion and Safety of the Spinal Simplicity Minuteman G5 Fusion Plate in Adults with Degenerative Lumbar Spine Conditions

What this Trial Is About

Researchers are evaluating the effectiveness and safety of the Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft material in patients with degenerative lumbar spine conditions causing chronic low back pain, lower extremity symptoms, and neurogenic claudication. This prospective, multi-center, open-label post-market study focuses on patients with these specific spinal issues and aims to assess functional motion outcomes after treatment. Participants will be treated with the Minuteman G5 Device, a titanium alloy fusion plate designed for minimally invasive spinal fusion. The study involves a single treatment arm where subjects receive the device and are followed at 1, 3, 6, and 12 months post-treatment. After the primary 12-month assessment, subjects are invited for annual follow-up visits up to 5 years to collect ongoing patient-reported outcomes and safety information. The 12-month visit may also include a CT scan to evaluate the spinal fusion. Throughout the study, participants will undergo gait and balance testing using BioMech Lab sensor technology to capture three-dimensional motion data analyzed via a mobile device. Patient-reported outcomes will assess pain, quality of life, and satisfaction at multiple time points. Safety reviews will occur annually, with visits conducted in person or remotely. The main outcomes measured include pain levels, disability, physical function, and spinal fusion status over a total follow-up of 5 years.

Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device