Superion™ IDS Device for Spinal Stenosis

Not currently recruiting at 26 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather real-world results for the Superion™ IDS device, used to treat spinal stenosis. Spinal stenosis occurs when spaces in the spine narrow, causing pain in areas such as the legs, buttocks, or groin. The trial seeks participants who experience ongoing pain relieved by activities like sitting or bending over. Those with only back pain or other pain conditions may not qualify. If the device functions as intended, it could provide relief for individuals struggling with this condition. As an unphased trial, this study allows participants to contribute to understanding the device's real-world effectiveness.

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.

What prior data suggests that the Superion™ IDS device is safe for spinal stenosis?

Research has shown that the Superion™ IDS device is generally safe for treating lumbar spinal stenosis, a condition causing back pain due to narrowing spaces in the spine. Studies have found that the Superion device is as safe as other common treatments, with fewer patients requiring more invasive surgeries later. This indicates that patients receiving the device are less likely to need additional, more serious operations.

One study found that the Superion interspinous spacer, a small device placed between bones in the spine, provides excellent long-term benefits by reducing pain and improving movement. It is important to note that while the device is designed to be safe, it has not been tested in patients with certain conditions, such as back pain without symptoms in the leg, buttock, or groin.

Overall, the device is approved for use and has shown positive safety results in people with spinal stenosis. However, as with any medical treatment, results can vary, so discussing personal risks and benefits with a healthcare provider is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Superion™ IDS device is unique because it offers a minimally invasive option for treating spinal stenosis. Unlike traditional surgical methods that might require more extensive cutting and longer recovery times, the Superion™ IDS device works through an indirect decompression system. This means it aims to relieve pressure on the spinal nerves with a less invasive approach, potentially leading to quicker recovery and less postoperative pain. Researchers are excited about this device because it could provide a safer and more comfortable alternative for patients, allowing them to get back to their daily activities sooner.

What evidence suggests that the Superion™ IDS device is effective for spinal stenosis?

Research has shown that the Superion™ IDS device, which participants in this trial will receive, effectively treats lumbar spinal stenosis. This condition narrows the space in the spine, causing pain, numbness, or cramping. Studies have found that the device offers excellent long-term pain relief, improves quality of life, and helps maintain mobility by preventing movements that worsen symptoms. Patients using this device have experienced lasting pain relief and better function. The procedure is minimally invasive, meaning it is less disruptive to the body and often does not require an overnight hospital stay. Overall, the Superion™ IDS device has a strong track record in effectively helping patients manage their spinal stenosis symptoms. ^{1 3 5 6 7}

Who Is on the Research Team?

Natalie Bloom Lyons

Principal Investigator

Boston Scientific Corporation

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6781846/

Interspinous Process Decompression With The Superion ... Interspinous process decompression (IPD) with stand-alone spacers has demonstrated excellent long-term clinical benefit for patients with lumbar spinal stenosis ...

2. bostonscientific.com bostonscientific.com/content/dam/elabeling/nm/92479815-02_Rev_A_Indirect_Decompression_System_s.pdf

Superion™ Indirect Decompression System The Superion Indirect Decompression System is indicated to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs. ( ...

3. painmedicinenews.com painmedicinenews.com/Interventional/Article/02-22/Interspinous-Spacer-Shown-Effective-for-Severe-Pain-of-Lumbar-Spinal-Stenosis/66081?ses=ogst

Interspinous Spacer Shown Effective for Severe Pain of ... “The spacer is able to block extension of the spinal canal, which can worsen stenosis and symptomatic neurogenic claudication.” The outpatient procedure is ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715922006225

Real-World Evaluation of an Interspinous Spacer Used for ... A growing body of published clinical evidence has demonstrated excellent long-term clinical benefit with sustained pain relief, improved quality of life and ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28479526/

Superion Interspinous Spacer Treatment of Moderate ... Objective: To determine 4-year clinical outcomes in patients with moderate lumbar spinal stenosis treated with minimally invasive stand-alone interspinous ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04563793

Postmarket Outcomes Study for Evaluation of the Superion ... The purpose of this outcomes study is to compile real-world outcomes for the commercially approved Indirect Decompression Systems (IDS) in routine clinical ...

7. rapm.bmj.com rapm.bmj.com/content/49/1/30

Comparison analysis of safety outcomes and the rate of ... These results showed ISD and MILD procedures have an equivalent safety profile. However, ISDs demonstrated lower rates of open decompression and MILD.