Superion™ IDS Device for Spinal Stenosis

Recruiting at 20 trial locations

Overseen By Ann Yamano

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Disqualifiers: Axial back pain, Fixed motor deficit, others

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

Compensation: Varies

Number of Visits: 60

Duration: Initial procedure

214 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to gather real-world results of using the Superion™ IDS device in everyday medical practice. The device is used to help patients with back problems by relieving pressure on their spinal nerves. It works by creating more space in the spine, which can reduce pain and discomfort.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the Superion™ IDS Device safe for humans?

The Superion™ IDS Device, used for treating lumbar spinal stenosis, is considered safe as it is a minimally invasive procedure that avoids direct surgical removal of tissue near nerves. It is FDA approved and has been shown to be effective and safe in clinical trials, offering a less invasive option compared to traditional surgery. ^{1 2 3 4 5}

How is the Superion™ IDS device treatment different from other treatments for spinal stenosis?

The Superion™ IDS device is a minimally invasive treatment for lumbar spinal stenosis that involves placing a small implant between the bones in the spine to relieve pressure on nerves, unlike traditional surgery that requires more extensive tissue removal. It is unique because it fills the gap between ineffective conservative treatments and more invasive surgeries, offering a less invasive option with significant symptom relief. ^{1 3 4 5 6}

Research Team

Natalie Bloom Lyons

Principal Investigator

Boston Scientific Corporation

Eligibility Criteria

This trial is for individuals over 45 with lumbar spinal stenosis, experiencing leg/buttock/groin pain that improves when bending forward. Participants must understand the study and commit to follow-ups. Exclusions include those with fixed motor deficits, conditions that could affect outcome reporting, involvement in conflicting trials, or only axial back pain.

Inclusion Criteria

I have signed an informed consent form in English.

I am 45 years old or older.

I have ongoing leg, buttock, or groin pain that gets better when I sit or bend.

Exclusion Criteria

I have a permanent weakness in my leg(s) due to spinal stenosis.

You have a medical or psychological condition, or external factors, that could make it difficult for the study to accurately measure the effects of the treatment on pain (such as a history of certain types of pain, involvement in legal cases, or work-related injuries).

Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Superion™ Indirect Decompression System (IDS) device

Initial procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular follow-up visits including a 24-month visit

Long-term follow-up

Participants are monitored for long-term outcomes and patient satisfaction

60 months

Follow-up visits at 36, 48, and 60 months

Treatment Details

Interventions

• Superion® IDS device
• Superion™ IDS device

Trial Overview The Superion™ IDS device is being tested to gather real-world data on its effectiveness in routine clinical practice for patients suffering from lumbar spinal stenosis.

Participant Groups

Group I: Superion™ IDS device Experimental Treatment 1 Intervention

Superion™ Indirect Decompression System (IDS)

Superion® IDS device is already approved in United States for the following indications:

Approved in United States as Superion Indirect Decompression System for:

• Moderate degenerative lumbar spinal stenosis with or without Grade 1 spondylolisthesis

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Findings from Research

The Superion Interspinous Spacer is a minimally invasive titanium implant designed to alleviate moderate radicular symptoms in patients with lumbar spinal stenosis by limiting spinal extension and reducing nerve impingement.

Initial clinical results suggest that the Superion device effectively fills the treatment gap between conservative care and invasive surgery, providing a new option for patients who do not respond to traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale, design and clinical performance of the Superion® Interspinous Spacer: a minimally invasive implant for treatment of lumbar spinal stenosis. Loguidice, V., Bini, W., Shabat, S., et al.[2011]

The Superion Interspinous Spacer was found to significantly improve back function and reduce pain in patients with moderate lumbar spinal stenosis (LSS), with a 64% improvement in the Oswestry Disability Index and a clinical success rate of 92% over 12 months.

The treatment was deemed safe, with only 5.0% of patients experiencing minor procedure-related adverse events, and only 5.9% requiring device explants, indicating a low risk associated with this minimally invasive intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive treatment of moderate lumbar spinal stenosis with the superion interspinous spacer. Bini, W., Miller, LE., Block, JE.[2021]

The Superion® interspinous spacer is an FDA-approved minimally invasive device that effectively prevents compression of neural elements in patients with spinal stenosis, showing very large effect sizes in improving disability and symptoms over 2 to 4 years.

This device offers a promising alternative to more invasive surgical options like decompressive laminectomy, potentially reducing the need for such procedures and addressing the growing demand for effective treatments for spinal stenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interspinous Process Decompression: Expanding Treatment Options for Lumbar Spinal Stenosis. Nunley, PD., Shamie, AN., Blumenthal, SL., et al.[2022]

The Superion interspinous spacer procedure is a minimally invasive option for patients with lumbar spinal stenosis who do not improve with conservative treatments, offering comparable outcomes to traditional laminectomy while potentially reducing costs.

Continuing conservative treatment for over 12 weeks yields only minimal improvements in pain and functionality, making surgical options more effective for patients who do not respond to initial therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness and Safety of Interspinous Process Decompression (Superion). Cairns, K., Deer, T., Sayed, D., et al.[2020]

In a 4-year study of 122 patients with moderate lumbar spinal stenosis, 84.3% of those treated with the Superion device showed clinical success in relieving symptoms, indicating its long-term efficacy.

Patients experienced significant improvements in various measures of pain and function, with very large effect sizes, demonstrating that the Superion device effectively alleviates symptoms of intermittent neurogenic claudication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superion Interspinous Spacer Treatment of Moderate Spinal Stenosis: 4-Year Results. Nunley, PD., Patel, VV., Orndorff, DG., et al.[2022]

In a 3-year study involving 391 patients with moderate degenerative lumbar spinal stenosis, the Superion(®) device showed a higher success rate (52.5%) compared to the X-STOP(®) control (38.0%) in achieving the primary composite endpoint, indicating its effectiveness in treating this condition.

Patients treated with Superion(®) maintained significant improvements in back and leg pain severity, as well as functional outcomes, demonstrating the long-term efficacy of this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superion(®) InterSpinous Spacer for treatment of moderate degenerative lumbar spinal stenosis: durable three-year results of a randomized controlled trial. Patel, VV., Nunley, PD., Whang, PG., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Rationale, design and clinical performance of the Superion® Interspinous Spacer: a minimally invasive implant for treatment of lumbar spinal stenosis. [2011]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Minimally invasive treatment of moderate lumbar spinal stenosis with the superion interspinous spacer. [2021]

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

Interspinous Process Decompression: Expanding Treatment Options for Lumbar Spinal Stenosis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Cost-effectiveness and Safety of Interspinous Process Decompression (Superion). [2020]

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

Superion Interspinous Spacer Treatment of Moderate Spinal Stenosis: 4-Year Results. [2022]

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

Superion(®) InterSpinous Spacer for treatment of moderate degenerative lumbar spinal stenosis: durable three-year results of a randomized controlled trial. [2022]