Actively Recruiting
The Stability Study: Post-Market Study of Functional Motion Outcomes With the Spinal Simplicity Minuteman G5 Fusion Plate in Degenerative Lumbar Spine Conditions
Led by Spinal Simplicity LLC · Updated on 2025-10-03
150
Participants Needed
6
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of the Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft material in patients with degenerative lumbar spine conditions causing chronic low back pain, lower extremity symptoms, and neurogenic claudication. This prospective, multi-center, open-label post-market study focuses on patients with these specific spinal issues and aims to assess functional motion outcomes after treatment. Participants will be treated with the Minuteman G5 Device, a titanium alloy fusion plate designed for minimally invasive spinal fusion. The study involves a single treatment arm where subjects receive the device and are followed at 1, 3, 6, and 12 months post-treatment. After the primary 12-month assessment, subjects are invited for annual follow-up visits up to 5 years to collect ongoing patient-reported outcomes and safety information. The 12-month visit may also include a CT scan to evaluate the spinal fusion. Throughout the study, participants will undergo gait and balance testing using BioMech Lab sensor technology to capture three-dimensional motion data analyzed via a mobile device. Patient-reported outcomes will assess pain, quality of life, and satisfaction at multiple time points. Safety reviews will occur annually, with visits conducted in person or remotely. The main outcomes measured include pain levels, disability, physical function, and spinal fusion status over a total follow-up of 5 years.
CONDITIONS
Brief 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 per labeled indication
- Be willing and capable of giving written consent to participate voluntarily
- Be willing and capable of subjective evaluation and able to read and understand questionnaires and 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
- Willing and able to comply with study-related procedures and visits
- On a stable pain medication regimen for at least 30 days prior to enrollment
- Must disclose any unresolved major issues of secondary gain, such as ongoing injury claims or worker's compensation claims (disclosure required but not exclusionary)
You will not qualify if you...
- Previous spinal surgery at the intervention level (e.g., lumbar fusion, discectomy, laminectomy), except MILD procedure
- Physically unable to perform gait and/or balance tests
- Current systemic or local infection increasing surgery risk
- History of medications decreasing bone quality or soft tissue healing as judged by Investigator
- Grade II-V spondylolisthesis
- Significant scoliosis with Cobb angle greater than 10 degrees
- Unremitting back pain in spinal flexion position
- Active systemic disease affecting subject welfare as judged by Investigator
- Concurrent participation in another clinical drug or device study that may confound results
- Vertebral osteoporosis or history of vertebral fracture
- Pregnant, lactating, or planning pregnancy during study and 3 months post-op; females of childbearing potential must use reliable birth control
- Malformation or dysplasia of spinous process
- Severe osteoporosis with T-score below -2.5 standard deviations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants are treated with the Minuteman G5 interspinous fusion device for degenerative lumbar spine conditions.
1 visit (in-person)
Duration - 12 months
Participants attend follow-up visits to assess pain, disability, quality of life, and spinal fusion, including gait and balance testing and patient-reported outcome measures.
Visits at 1, 3, 6, and 12 months post-treatment
Duration - Up to 5 years
After the 12-month visit, participants complete annual visits through 5 years to collect patient-reported outcomes, safety reviews, which may be completed in person or remotely.
Annual visits
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
A
Adam Rogers
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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