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
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Georgia
Vista Clinical Research
RECRUITING
Newnan
Indiana
Comprehensive Pain & Spine Specialists
RECRUITING
Indianapolis
Kansas
University of Kansas Medical Center
NOT_YET_RECRUITING
Kansas City
Minnesota
Nura Precision Pain Management
RECRUITING
Edina
Oregon
Pacific Sports & Spine
RECRUITING
Eugene
West Virginia
Spine & Nerve Center of the Virginias
RECRUITING
Charleston
Contact Information
Primary
Echo Cundiff
ecundiff@spinalsimplicity.com
913-451-4414
Backup
Adam Rogers
arogers@spinalsimplicity.com
913-451-4414
Time Frame
Start Date: 2024-05-29
Estimated Completion Date: 2030-12
Participants
Target number of participants: 150
Treatments
Other: Surgical Group
patient treated with Minuteman G5 interspinous fusion device 510k cleared for degenerative conditions of the lumbar spine
Related Therapeutic Areas
Sponsors
Leads: Spinal Simplicity LLC

This content was sourced from clinicaltrials.gov