Evaluation of a new device for treating low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety and effectiveness of the Aurora Spine ZIP™ MIS Interspinous Fusion System combined with bone graft material for patients suffering from chronic low back pain due to degenerative disc disease and neurogenic claudication. The device is designed to facilitate single-level spinal fusion through a minimally invasive interlaminar approach. Participants will be monitored for improvements in pain and function following the procedure, with a focus on those who have not found relief from non-operative treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects enrolled in this study must meet ALL of the following inclusion criteria:

  1. Subject must provide written informed consent prior to any clinical study-related procedure.
  2. Subject is at least 18 years or older at the time of enrollment, skeletal mature.
  3. 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).
  4. MRI within 12 months prior to the procedure with at least mild to moderate spinal stenosis at the index treatment level
  5. Subject has undergone at least 3 months of non-operative treatment.
  6. Subject presents with ZCQ physical function ≥ 2.0 at baseline.
  7. Subject reports relief from lumbar flexion and/or sitting.
  8. Subject has baseline VAS of back and/or leg pain standing or walking ≥ 50mm.

Exclusion Criteria:

* Subjects enrolled in this study must NOT meet any of the following exclusion criteria:

  1. Subject is unable to provide written informed consent.
  2. Subject has had previous lumbar spine surgery at the intended treatment level (e.g., laminectomy or fusion).
  3. Subject has a grade II or greater spondylolisthesis on flexion and extension radiographs with 3mm instability.
  4. Subject has confirmed or suspected osteoporosis or osteopenia.
  5. Subject is enrolled, or intends to participate, in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug, or additional testing beyond standard of care procedures) which could confound the results of this trial as determined by the investigator.
  6. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements.
  7. Subject is pregnant or nursing.

Where it's running

• The Raso Pain Center
  Jupiter, Florida, United States Recruiting
• Koga Neurosurgery
  Slidell, Louisiana, United States Recruiting
• National Spine and Pain Centers
  Oxon Hill, Maryland, United States Recruiting
• Comprehensive & Interventional Pain Management
  Henderson, Nevada, United States Recruiting
• Nevada Advanced Pain Specialists
  Reno, Nevada, United States Recruiting
• Reno Tahoe Pain Associates
  Reno, Nevada, United States Recruiting

Study contacts

• Study coordinator: Shelley Trimm, BS
• Email: strimm@pacificresearchinstitute.care
• Phone: 7075085527

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.