What side effects are associated with this type of intervention?

Common treatments for Lumbar Spinal Stenosis similar to the Superion™ IDS include interspinous devices and surgical decompression. The side effects of these treatments can include complications such as infection, bleeding, and nerve damage. Specifically, for interspinous devices, there may be risks of device dislocation, fracture, or failure, and potential worsening of symptoms. Surgical decompression can also lead to complications like dural tears, instability of the spine, and the need for additional surgeries. Both treatments aim to alleviate pain and improve function but come with these potential risks.

What prior FDA approvals exist?

The FDA has approved several treatments for Lumbar Spinal Stenosis (LSS), including devices and procedures that aim to decompress the spinal canal. One notable approval is the Superion™ Indirect Decompression System (IDS), which is designed to treat moderate LSS by limiting spinal extension and preserving flexion. This minimally invasive device is implanted between the spinous processes to relieve pressure on the spinal nerves. Other similar treatments include the X-STOP Interspinous Process Decompression (IPD) System, which also aims to alleviate symptoms by preventing extension of the lumbar spine. These devices offer an alternative to more invasive surgical procedures, providing symptom relief while maintaining spinal stability.

What other types of research exist?

Promising novel alternatives to Superion™ IDS for Lumbar Spinal Stenosis patients include: 1) Minimally Invasive Lumbar Decompression (MILD) procedures, which remove small portions of ligament and bone to relieve pressure on the spinal nerves. 2) Interspinous Process Decompression (IPD) devices, such as the Vertiflex™ Procedure, which aim to maintain spinal canal space and reduce nerve compression. 3) Endoscopic Spine Surgery, which uses small incisions and an endoscope to perform decompression with minimal tissue disruption. These alternatives offer minimally invasive options with the potential for quicker recovery and reduced complications.

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Spinal Implant

Superion™ IDS Device for Spinal Stenosis

N/A

Recruiting

Research Sponsored by Boston Scientific Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

45 years of age or older when written informed consent is obtained

Persistent leg/buttock/groin pain, with or without back pain that is consistently relieved by flexion activities (example: sitting or bending over a shopping cart)

Must not have

Fixed motor deficit in lower extremity(ies) due to LSS

Axial back pain only

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24-, 36-, 48- and 60-months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, typical risks may include discomfort at the implant site, potential nerve damage, infection risk post-surgery and possible failure of the device to relieve symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 45 years old or older.

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

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I have been diagnosed with narrowing of the spinal canal in my lower back.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My back pain is only in the middle part of my back.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24-, 36-, 48- and 60-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24-, 36-, 48- and 60-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-, 36-, 48- and 60-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of success at the 24-month follow-up visit

Secondary study objectives

Patient Satisfaction: VertiFlex® Patient Satisfaction Survey

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Superion™ IDS deviceExperimental Treatment1 Intervention

Superion™ Indirect Decompression System (IDS)

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Lumbar Spinal Stenosis (LSS) aim to alleviate pressure on the spinal cord and nerves, thereby reducing pain and improving mobility. The Superion™ IDS device achieves this through indirect decompression by limiting spinal extension and preserving flexion, which helps to widen the spinal canal and reduce nerve compression. Physical therapy focuses on strengthening the core and improving flexibility to support the spine and reduce strain. Pharmacologic treatments, such as NSAIDs and muscle relaxants, help manage inflammation and muscle spasms. Interventional procedures like epidural steroid injections provide temporary pain relief by reducing inflammation around the compressed nerves. These treatments are crucial for LSS patients as they target the underlying causes of pain and functional impairment, thereby enhancing quality of life.