Minuteman G5 for Lumbar Spinal Stenosis

(STABILITY Trial)

Recruiting at 7 trial locations

Overseen By Adam Rogers

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates how well the Minuteman G5 device aids individuals with lumbar spinal stenosis, a condition where the lower spine narrows, causing back and leg pain. The main goal is to determine if this treatment can safely reduce pain and improve movement for those who have not found relief with other treatments. It is most suitable for individuals who have experienced low back pain with leg symptoms and difficulty walking for at least three months. Participants should not have undergone previous back surgery at the treatment site and must be stable on their pain medication for at least 30 days before joining. As an unphased trial, this study offers a unique opportunity for patients to explore a new treatment option that might provide relief when other methods have not.

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 prior data suggests that the Minuteman G5 device is safe for treating lumbar spinal stenosis?

Research has shown that the Minuteman G5 device is generally well-tolerated for treating lumbar spinal stenosis, a condition involving the narrowing of spaces in the spine. In one study, 89% of patients using the Minuteman device achieved successful fusion, indicating long-term spine stability and treatment effectiveness. Another study found the device highly effective in relieving leg pain, with success rates between 84-88% at various follow-up times.

Overall, the Minuteman G5 has been used safely in patients with back pain and leg symptoms. Its approval for these conditions suggests its safety. However, as with any medical treatment, discussing individual risks with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for lumbar spinal stenosis, like laminectomy and spinal fusion, involve invasive surgery to relieve pressure on the spinal nerves. The Minuteman G5 is unique because it is an interspinous fusion device that can be implanted with a minimally invasive approach. This means less trauma to the body, potentially shorter recovery times, and fewer complications compared to traditional surgical methods. Researchers are excited because this device's design could offer a safer and more efficient alternative for patients suffering from degenerative lumbar conditions.

What evidence suggests that the Minuteman G5 is effective for lumbar spinal stenosis?

Research has shown that the Minuteman G5 device, which participants in this trial will receive, effectively treats wear-and-tear conditions of the lower back. In one study, 89% of patients experienced successful fusion, meaning their bones joined together well, providing long-term stability. Another study found that 84% to 88% of patients reported less leg pain at various follow-up times. These results suggest that the Minuteman G5 can help reduce pain and improve function in people with lower back issues. ^{1 2 3 5 6}

Who Is on the Research Team?

Tom Hedman, PhD

Principal Investigator

Spinal Simplicity

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. spinalsimplicity.com spinalsimplicity.com/minuteman/

The Minuteman® Procedure | Spinal ... By strictly adhering to known principles of lumbar arthrodesis, Skoblar et al. recently reported successful fusion outcomes in 93% of patients utilizing the ...

2. trials.arthritis.org trials.arthritis.org/trials/NCT06355791

Post-Market Clinical Study of Functional Motion Outcomes in ... The indication for the device under study is degenerative conditions of the lumbar spine resulting in back pain with lower extremity symptoms and neurogenic ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11182879/

24-Month Outcomes of Indirect Decompression Using a ... Clinical success rates for leg pain at the 8-week, 6-month, 12-month and 24-month follow-up visits for decompression were 84%, 84%, 88% and 76% ...

4. spinalsimplicity.com spinalsimplicity.com/two-year-data/

2-Year Data From a Prospective Randomized Controlled ... Notably, 89% of the evaluated patients treated with the Minuteman device achieved successful fusion, indicating excellent long-term stability and efficacy of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12399849/

Safety and Efficacy of Interspinous Fixation Device via Lateral ... ISFD is a valuable tool in the treatment of moderate LSS and degenerative disc disease which has decreased morbidity and significant efficacy.

6. nuraclinics.com nuraclinics.com/wp-content/uploads/2024/08/Functional-Outcomes-for-Patients-with-Lumbar-Spinal-Stenosis-Treated-with-MinuteMan.pdf

Functional-Outcomes-for-Patients-with-Lumbar-Spinal- ... Our data suggests the MinuteMan treatment results in an improvement in walking and standing with or without combined SCS therapy for a typical pain patient.