NCT06355791

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

The Stability Study: Open-Label, Multi-Center, Post-Market Study of Functional Motion Outcomes In Subjects Treated With the Spinal Simplicity Minuteman G5 Fusion Plate

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Spinal Simplicity LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 the primary assessment at 12-months post-treatment subject will be offered a computerized topography (CT) scan to evaluate spinal fusion. After completion of the Month 12 visit all subjects will be asked to complete annual visits through 5 years, which include collection of PROMs, safety review, and can be completed in person or remote.

Conditions

• Degenerative Conditions of the Lumbar Spine
• Lumbar Spinal Stenosis
• Spondylolisthesis

Interventions

Type	Name	Description
DEVICE	Minuteman G5 Device	The Minuteman G5 MIS Fusion Plate consists of spinous process plates and surgical instruments. Implants are made of Titanium alloy

Timeline

• Start date: 2024-05-29
• Primary completion: 2026-12-01
• Completion: 2030-12-01
• First posted: 2024-04-09
• Last updated: 2025-10-03

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study