Actively Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Led by Spinal Simplicity LLC · Updated on 2025-10-03
150
Participants Needed
6
Research Sites
339 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be a candidate for the Spinal Simplicity Minuteman G5 Fusion Plate device as per its labeled indication
- Be willing and able to give written consent to participate voluntarily
- Be able to understand and complete written questionnaires and informed consent
- Be 18 years of age or older at enrollment
- Diagnosed with degenerative lumbar spine conditions causing chronic low back pain with lower extremity symptoms and neurogenic claudication
- Have received at least 3 months of non-operative or conservative treatment without significant benefit
- Be willing and able to follow all study procedures and visits
- Be on a stable pain medication regimen for at least 30 days before enrollment
- Disclose any unresolved issues of secondary gain, such as ongoing injury claims or worker's compensation, though these will not exclude participation
You will not qualify if you...
- Previous spinal surgery at the intervention level (except MILD procedure)
- Physically unable to perform gait or balance tests
- Current systemic or local infection increasing surgery risk
- Use of medications that reduce bone quality or tissue healing
- Grade II to V spondylolisthesis
- Significant scoliosis with Cobb angle over 10 degrees
- Unremitting back pain when bending forward
- Active systemic disease affecting health
- Participation in another clinical drug or device study that may affect results
- Vertebral osteoporosis or history of vertebral fracture
- Pregnant, lactating, or planning pregnancy through 3 months post-op (with required birth control if applicable)
- Malformation or dysplasia of the spinous process
- Severe osteoporosis with T score less than -2.5 SD
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Vista Clinical Research
Newnan, Georgia, United States, 30265
Actively Recruiting
2
Comprehensive Pain & Spine Specialists
Indianapolis, Indiana, United States, 46250
Actively Recruiting
3
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Not Yet Recruiting
4
Nura Precision Pain Management
Edina, Minnesota, United States, 55435
Actively Recruiting
5
Pacific Sports & Spine
Eugene, Oregon, United States, 97404
Actively Recruiting
6
Spine & Nerve Center of the Virginias
Charleston, West Virginia, United States, 25301
Actively Recruiting
Research Team
E
Echo Cundiff
CONTACT
A
Adam Rogers
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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