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

Inclusion criteria

• A subject must MEET ALL of the following inclusion criteria:
• Be a candidate for Spinal Simplicity Minuteman G5 Fusion Plate device per labeled indication
• 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
• Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand the written informed consent
• Be 18 years of age or older at the time of enrollment
• Have been diagnosed with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication
• Received at least 3 months of non-operative or conservative treatment without significant benefit in the opinion of the Investigator
• Be willing and able to comply with study-related requirements, procedures and visits
• Be on a stable pain medication regimen, as determined by the Investigator, for at least 30 days prior to enrolling in this study.
• Must disclose any unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the Investigator. Including being involved in an injury claim under current litigation or has a pending or approved worker's compensation claim. Subjects will not be excluded due to secondary gain, but it should be disclosed at Enrollment.

Exclusion criteria

• A subject must NOT MEET ANY of the following exclusion criteria:
• Had previous spinal surgery at the level of intervention (e.g. lumbar fusion, discectomy, Laminectomy) MILD procedure is not considered an exclusion.
• Patient physically unable to perform the Gait and/or Balance tests.
• Current systemic infection or local infection increasing the risk of surgery
• History of medications decreasing bone quality or soft tissue healing in the opinion of the Investigator
• Grade II-V spondylolisthesis
• Significant scoliosis with Cobb angle \>10 degrees
• Unremitting back pain in a spinal flexion position
• Active systemic disease that may affect the welfare of the subject in the opinion of the Investigator
• Be concurrently participating in another clinical drug and/or device study that may alter or confound the results of the assessment (investigational device, investigational drug, new indication for a device or drug, or additional testing beyond standard of care procedures) as determined by the investigator.
• Vertebral osteoporosis or history of vertebral fracture
• Be pregnant/ lactating or plan to become pregnant from study enrollment through 3 months post-operatively. (determined by urine testing unless female subject is surgical sterile or post-menopausal). If female, sexually active and childbearing age, subject must be willing to use a reliable form of birth control through the 3-month visit.
• Malformation or dysplasia of spinous process
• Severe osteoporosis with T score \<-2.5 SD