NCT05504499 · Pacific Research Institute
REFINE Study: A Study In a Novel Interspinous Fusion Device In Subjects With Low Back Pain
(Refine)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects enrolled in this study must meet ALL of the following inclusion criteria:
- 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 criteria
- Subjects enrolled in this study must NOT meet any of the following exclusion criteria:
- 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.
Where
- Santa Rosa, California
- Jupiter, Florida
- Slidell, Louisiana
- Oxon Hill, Maryland
- Henderson, Nevada
- Reno, Nevada
- Voorhees Township, New Jersey
- Loveland, Ohio
- Chadds Ford, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 18, 2022 · Source of record for eligibility and locations