Motion and recovery after Minuteman G5 lumbar fusion

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

This trial will test whether the Minuteman G5 fusion plate plus bone graft improves walking, balance, pain, and quality of life for adults with degenerative lumbar spine disease and neurogenic claudication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Spinal Simplicity LLC (Industry-sponsored)
• Locations: 6 sites (Newnan, Georgia and 5 other locations)
• Trial ID: NCT06355791 on ClinicalTrials.gov

What this trial studies

This is an open-label, single-arm post-market study enrolling up to 150 adults treated with the Minuteman G5 MIS fusion plate and bone graft at multiple U.S. centers. Subjects will be followed at 1, 3, 6, and 12 months after treatment with gait and balance testing using BioMech Lab sensors to capture three-dimensional motion and mobile-device analysis, alongside patient-reported outcome measures for pain, quality of life, and satisfaction. A CT scan to evaluate fusion will be offered at the 12-month visit, and participants will be asked to complete annual remote or in-person PROMs and safety reviews through year five. The study collects objective motion data and standard clinical outcomes to characterize functional recovery after device implantation.

Who should consider this trial

Good fit: Adults aged 18 or older with degenerative lumbar spine conditions causing chronic low back pain, lower extremity symptoms, and neurogenic claudication who have not improved after at least three months of conservative care and are candidates for the Minuteman G5 per its labeled indication.

Not a fit: Patients who have other non-spinal causes of leg symptoms, active infection, very poor bone quality, or who are not appropriate surgical candidates are unlikely to benefit from this fusion device.

Why it matters

Potential benefit: If successful, the device could help improve walking, balance, pain, and overall function for people with degenerative lumbar disease and neurogenic claudication.

How similar studies have performed: Minimally invasive lumbar fusion devices have previously shown improvements in pain and function, but device-specific, motion-capture outcomes of this type are limited in the literature.

Eligibility criteria

Inclusion Criteria

A subject must MEET ALL of the following inclusion criteria:

1. Be a candidate for Spinal Simplicity Minuteman G5 Fusion Plate device per labeled indication
2. 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
3. Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand the written informed consent
4. Be 18 years of age or older at the time of enrollment
5. Have been diagnosed with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication
6. Received at least 3 months of non-operative or conservative treatment without significant benefit in the opinion of the Investigator
7. Be willing and able to comply with study-related requirements, procedures and visits
8. Be on a stable pain medication regimen, as determined by the Investigator, for at least 30 days prior to enrolling in this study.
9. 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.

Exclusion Criteria

A subject must NOT MEET ANY of the following exclusion criteria:

1. Had previous spinal surgery at the level of intervention (e.g. lumbar fusion, discectomy, Laminectomy) MILD procedure is not considered an exclusion.
2. Patient physically unable to perform the Gait and/or Balance tests.
3. Current systemic infection or local infection increasing the risk of surgery
4. History of medications decreasing bone quality or soft tissue healing in the opinion of the Investigator
5. Grade II-V spondylolisthesis
6. Significant scoliosis with Cobb angle \>10 degrees
7. Unremitting back pain in a spinal flexion position
8. Active systemic disease that may affect the welfare of the subject in the opinion of the Investigator
9. Be concurrently participating in another clinical drug and/or device study that may alter or confound the results of the assessment (investigational device, investigational drug, new indication for a device or drug, or additional testing beyond standard of care procedures) as determined by the investigator.
10. Vertebral osteoporosis or history of vertebral fracture
11. Be pregnant/ lactating or plan to become pregnant from study enrollment through 3 months post-operatively. (determined by urine testing unless female subject is surgical sterile or post-menopausal). If female, sexually active and childbearing age, subject must be willing to use a reliable form of birth control through the 3-month visit.
12. Malformation or dysplasia of spinous process
13. Severe osteoporosis with T score \<-2.5 SD

Where this trial is running

Newnan, Georgia and 5 other locations

• Vista Clinical Research — Newnan, Georgia, United States (Recruiting)
• Comprehensive Pain & Spine Specialists — Indianapolis, Indiana, United States (Recruiting)
• University of Kansas Medical Center — Kansas City, Kansas, United States (Not_yet_recruiting)
• Nura Precision Pain Management — Edina, Minnesota, United States (Recruiting)
• Pacific Sports & Spine — Eugene, Oregon, United States (Recruiting)
• Spine & Nerve Center of the Virginias — Charleston, West Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Echo Cundiff

Conditions Degenerative Conditions of the Lumbar Spine; Lumbar Spinal Stenosis; Spondylolisthesis