Minuteman G5 for Lumbar Spinal Stenosis

(STABILITY Trial)

Recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spinal Simplicity LLC

Must be taking: Pain medications

Must not be taking: Bone quality medications

Disqualifiers: Previous spinal surgery, Spondylolisthesis, Scoliosis, Osteoporosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Baseline to 12 months

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you be on a stable pain medication regimen for at least 30 days before enrolling, so you may not need to stop your current medications. However, it's best to discuss your specific situation with the trial investigator.

What data supports the effectiveness of the treatment Minuteman G5 for Lumbar Spinal Stenosis?

The Minuteman G3, a similar treatment to Minuteman G5, is a minimally invasive device used for spinal fusion and has been shown to be safe and effective for treating lumbar spinal stenosis, with potential to improve patient outcomes and disrupt current treatment methods. ^{1 2 3 4 5}

Is the Minuteman G5 treatment generally safe for humans?

The Minuteman device, similar to other minimally invasive procedures for lumbar spinal stenosis, is generally considered safe based on available scientific literature. ^{3 6 7 8 9}

How does the Minuteman G5 treatment for lumbar spinal stenosis differ from other treatments?

The Minuteman G5 is a minimally invasive device designed for interspinous-interlaminar fusion, which provides temporary fixation of the spine and eventually leads to bony fusion. This approach is unique compared to other treatments like the MILD procedure or Vertiflex, which focus on decompression without fusion, offering a different mechanism of action for treating lumbar spinal stenosis. ^{3 4 10 11 12}

What is the purpose of this trial?

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.

Research Team

Tom Hedman, PhD

Principal Investigator

Spinal Simplicity

Eligibility Criteria

This trial is for adults with chronic low back pain, leg symptoms, and neurogenic claudication due to degenerative conditions like spinal stenosis or spondylolisthesis in the lumbar spine. Specific eligibility criteria are not provided but typically include a detailed medical history and current health status.

Inclusion Criteria

Subject must provide informed written consent prior to any study related procedure or assessment

I have undergone non-surgical treatment for at least 3 months.

My doctor recommends a Minuteman G5 Fusion Plate for my lower back condition.

Exclusion Criteria

Pregnant or lactating female prior or during the surgical period and 3 months post-operatively

I have constant back pain when I bend forward.

I have taken medications that could weaken my bones or slow healing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with the Minuteman G5 Device for degenerative conditions of the lumbar spine

Baseline to 12 months

Visits at baseline, 1, 3, 6, and 12 months

Primary Assessment

Primary assessment includes gait and balance testing, patient-reported outcome measures, and optional CT scan for spinal fusion evaluation

12 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness annually through 5 years, including collection of PROMs and safety review

4 years

Annual visits (in-person or remote)

Treatment Details

Interventions

• Minuteman G5

Trial Overview The Stability Study tests the Minuteman G5 MIS Fusion Plate combined with bone graft material for safety and effectiveness in relieving symptoms associated with degenerative lumbar spine conditions.

Participant Groups

Group I: Surgical Group Experimental Treatment 1 Intervention

patient treated with Minuteman G5 interspinous fusion device 510k cleared for degenerative conditions of the lumbar spine

Who Is Running the Clinical Trial?

Spinal Simplicity LLC

Lead Sponsor

Trials

2

Recruited

200+

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Analysis of dynamic implants use in surgical treatment of degenerative lumbar spine stenosis]. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Influence of diabetes mellitus on patients with lumbar spinal stenosis: A nationwide population-based study. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

A Comprehensive Review of Novel Interventional Techniques for Chronic Pain: Spinal Stenosis and Degenerative Disc Disease-MILD Percutaneous Image Guided Lumbar Decompression, Vertiflex Interspinous Spacer, MinuteMan G3 Interspinous-Interlaminar Fusion. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

mild(®) Lumbar Decompression for the Treatment of Lumbar Spinal Stenosis. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

The Implication of Preoperative Central Stenosis on Patient-Reported Outcomes After Lumbar Decompression Surgery. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Systematic safety review and meta-analysis of procedural experience using percutaneous access to treat symptomatic lumbar spinal stenosis. [2012]

7. United States pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes for Lumbar Fusion in Patients with Previously Treated Cervical Myelopathy. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Nonsurgical integrative inpatient treatments for symptomatic lumbar spinal stenosis: a multi-arm randomized controlled pilot trial. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

The Impact of Age on the Outcomes of Minimally Invasive Lumbar Decompression for Lumbar Spinal Stenosis. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Contribution of neuromuscular impairment to physical functional status in patients with lumbar spinal stenosis. [2010]

11. France pubmed.ncbi.nlm.nih.gov

[Less invasive calibration of lumbar canal stenosis. Results with a tubular muscle retraction system used in 35 patients]. [2007]

12. United States pubmed.ncbi.nlm.nih.gov

Decompression surgery improves gait quality in patients with symptomatic lumbar spinal stenosis. [2019]