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The Stability Study — STABILITY  

Lumbar Spinal Stenosis Clinical Trial

Official title:
The Stability Study: Functional Motion Outcomes In Patients Treated With An Interspinous Fusion Device For Degenerative Conditions Of The Lumbar Spine

Clinical Trial Summary

The studied indication is degenerative conditions of the lumbar spine resulting in back pain with lower extremity symptoms and neurogenic claudication. The purpose of this study is to evaluate the effectiveness and safety of instrumented posterior arthrodesis using the 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.

Clinical Trial Description

For this study, gait and balance tests will be performed using BioMech Lab. BioMech Lab uses sensor technology to capture and deliver three-dimensional patient motion data to a mobile device that instantly analyzes, distills, and quantifies the information. BioMech Lab provides real-time feedback and reporting. This study evaluates whether BioMech Lab gait and balance tests provide additional objective actionable intelligence with higher granularity and accuracy for the clinicians, patients, Spinal Simplicity, and the medical community. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06355791
Study type Interventional
Source Spinal Simplicity LLC
Contact
Status Enrolling by invitation
Phase N/A
Start date April 15, 2024
Completion date September 30, 2025
View Details
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