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

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.

NCT Number	NCT06355791
Lead Sponsor	Spinal Simplicity LLC
Conditions	Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis, Spondylolisthesis
Enrollment	150 participants
Start Date	2024-05-29
Primary Completion	2026-12 (estimated)
Study Completion	2030-12 (estimated)
Updated on ClinicalTrials.gov	2025-10-03