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Interspinous Fusion Device

Interspinous Fusion for Lower Back Pain (Refine Trial)

N/A

Recruiting

Research Sponsored by Pacific Research Institute

Eligibility Criteria Checklist

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

Must have

Subject has 1-2 symptomatic lumbar degenerative disease at adjacent level, T12-S1, with or without grade I spondylolisthesis (confirmed by history and radiographic studies).

Subject has baseline VAS of back and/or leg pain standing or walking ≥ 50mm.

Must not have

Subject has confirmed or suspected osteoporosis or osteopenia.

Subject is unable to provide written informed consent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether the Aurora Spine ZIP MIS Interspinous Fusion System is an effective and safe treatment for patients with chronic low back pain and degenerative disc disease who also have neurogenic claudication.

Who is the study for?

This trial is for adults over 18 with chronic low back pain due to degenerative disc disease and mild to moderate spinal stenosis, who've tried non-surgical treatments for at least 3 months. Candidates should find relief in lumbar flexion/sitting and have significant pain while standing or walking. Exclusions include previous surgery at the treatment level, severe spondylolisthesis, osteoporosis, participation in other trials that could affect results, and pregnancy.

What is being tested?

The REFINE Study tests the Aurora Spine ZIP™ MIS Interspinous Fusion System with bone graft material on patients with lower back pain from spinal conditions. It aims to assess how effective and safe this fusion device is when treating chronic back pain associated with degenerative diseases of the spine.

What are the potential side effects?

While specific side effects are not listed here, typical risks of interspinous fusion procedures can include infection, nerve damage leading to numbness or weakness, bleeding, persistent pain at the bone graft site or new onset of pain.

Eligibility Criteria

Inclusion Criteria

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

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I have lower back issues due to degenerative disease in 1-2 spots from T12 to S1, with or without a slight spine misalignment.

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I experience significant back or leg pain when standing or walking.

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My MRI shows I have mild to moderate spinal narrowing where I will be treated.

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I am 18 years or older and my bones have stopped growing.

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My back or leg pain when standing or walking is moderate to severe.

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My MRI shows I have mild to moderate spinal stenosis.

Exclusion Criteria

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

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I have been diagnosed with or suspected to have weak bones.

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I am unable to sign a consent form.

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I have had surgery on my lower back at the same spot that needs treatment now.

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My spine condition shows a grade II or higher slippage with 3mm movement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

To evaluate the efficacy and safety of the Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material based on improvement in composite endpoints relative to baseline at 3 and 12 months 1. > 20mm pain reduction in VAS Back while standing

Secondary study objectives

Complication Rate

Imaging analysis

To characterize patient global impression of change (PGIC) relative to baseline at 3 and 12 months.

+2 more

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: Single ArmExperimental Treatment1 Intervention

A Prospective, Open-Label, Non-Randomized, Multi-Center Study Measuring Functional Outcomes In a Novel Interspinous Fusion Device In Subjects With Low Back Pain A Prospective, Observational, Open-Label, Non-Randomized, Multi-Center Study Measuring Functional Outcomes In a Novel Interspinous Fusion Device In Subjects With Low Back Pain

0 / 10Eligibility criteria met