Evaluation of a new device for treating low back pain

REFINE Study: 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

This study is testing a new device to see if it can safely help people with chronic low back pain from degenerative disc disease feel better when other treatments haven't worked.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Pacific Research Institute (Research network)
• Locations: 10 sites (Santa Rosa, California and 9 other locations)
• Trial ID: NCT05504499 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with symptomatic lumbar degenerative disease and spinal stenosis who have not responded to conservative treatments.

Not a fit: Patients with severe spinal conditions or those who have not undergone prior non-operative treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with chronic low back pain, potentially improving their quality of life.

How similar studies have performed: Other studies have shown promise with similar interspinous fusion devices, suggesting potential for success in this approach.

Eligibility criteria

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 this trial is running

Santa Rosa, California and 9 other locations

• Evolve Restorative Center — Santa Rosa, California, United States (Active_not_recruiting)
• 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)
• The Pain Management Center — Voorhees Township, New Jersey, United States (Recruiting)
• Premier Pain Treatment Institute — Loveland, Ohio, United States (Recruiting)
• Center for Interventional Pain and Spine — Chadds Ford, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Shelley Trimm, BS

Conditions Lumbar Spinal Stenosis