REFINE Study: A Study In a Novel Interspinous Fusion Device In Subjects With 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
Pacific Research Institute
100 participants
Mar 19, 2021
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the effectiveness and safety of the use of Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material in fusion in patients with chronic low back pain that present with degenerative disc disease with concurrent neurogenic claudication.
Eligibility
Inclusion Criteria8
- Subject must provide written informed consent prior to any clinical study-related procedure.
- Subject is at least 18 years or older at the time of enrollment, skeletal mature.
- 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).
- MRI within 12 months prior to the procedure with at least mild to moderate spinal stenosis at the index treatment level
- Subject has undergone at least 3 months of non-operative treatment.
- Subject presents with ZCQ physical function ≥ 2.0 at baseline.
- Subject reports relief from lumbar flexion and/or sitting.
- Subject has baseline VAS of back and/or leg pain standing or walking ≥ 50mm.
Exclusion Criteria7
- Subject is unable to provide written informed consent.
- Subject has had previous lumbar spine surgery at the intended treatment level (e.g., laminectomy or fusion).
- Subject has a grade II or greater spondylolisthesis on flexion and extension radiographs with 3mm instability.
- Subject has confirmed or suspected osteoporosis or osteopenia.
- 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.
- 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.
- Subject is pregnant or nursing.
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Interventions
The intended study population are adults 18 years or older with symptomatic lumbar degenerative disc disease resulting in back pain with lower extremity symptoms and neurogenic claudication that improves with spinal flexion who are candidates for use of the Zip™ MIS Interspinous Fusion device when undergoing spinal fixation procedures.
Locations(10)
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NCT05504499