Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355791
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-16
First Post:
2024-03-26
Brief Title:
The Stability Study
Sponsor:
Spinal Simplicity LLC
Organization:
Spinal Simplicity LLC
Study Overview
Official Title:
The Stability Study Functional Motion Outcomes In Patients Treated With An Interspinous Fusion Device For Degenerative Conditions Of The Lumbar Spine
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STABILITY
Brief 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
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
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None