Spinal Simplicity LLC
This is a prospective, multi-center open-label single arm post-market study where the purpose is to evaluate the effectiveness and safety of the market approved Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft material in patients with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication. The indication for the device under study is degenerative conditions of the lumbar spine resulting in back pain with lower extremity symptoms and neurogenic claudication.
Up to 150 subjects will be enrolled and treated at up to 20 study sites. Qualified subjects will be enrolled and treated with the Minuteman G5 Device. Subjects will be seen at 1-, 3-, 6- and 12-months following study treatment. Key outcome assessments will include gait and balance testing performed using BioMech Lab sensor technology to capture and deliver three-dimensional patient motion data to a mobile device that instantly analyzes, distills, and quantifies the information. Patient reported outcome measures will also be collected to evaluate pain, quality of life and satisfaction. During…
Inclusion Criteria A subject must MEET ALL of the following inclusion criteria: 1. Be a candidate for Spinal Simplicity Minuteman G5 Fusion Plate device per labeled indication 2. Be willing and capable of giving written consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided 3. Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand the written informed consent 4. Be 18 years of age or older at the time of enrollment 5. Have been diagnosed…
The Minuteman G5 MIS Fusion Plate consists of spinous process plates and surgical instruments. Implants are made of Titanium alloy