Lumbar Spinal Stenosis study: Interspinous Fusion
Official title REFINE Study: A Study In a Novel Interspinous Fusion Device In Subjects With Low Back Pain
ClinicalTrials.gov ID: NCT05504499
What this study is testing
- What it's testing
- This study is testing whether the Aurora Spine ZIP device and bone graft can safely and effectively help people with chronic low back pain and spinal stenosis.
- Who it's for
- You may be able to join if you have chronic low back pain and spinal stenosis caused by degenerative disc disease and you have neurogenic claudication.
- What's involved
- You would have the device implanted in your spine and receive bone graft material. You will have follow‑up visits and tests to check how well it works and if it is safe.
- Time commitment
- The study lasts about a year, with several visits after surgery to monitor progress.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- people enrolled in this study must meet ALL of the following
- 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...
- MRI within 12 months prior to the procedure with at least mild to moderate spinal stenosis at the index treatment level
You likely can't join if
- 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...
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could...
See the full eligibility criteria
- people enrolled in this study must meet ALL of the following
- 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.
- 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...
- 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...
- Subject is pregnant or nursing.
The study team makes the final eligibility decision.
Where it is enrolling
- Jupiter, Florida, United States
- Slidell, Louisiana, United States
- Oxon Hill, Maryland, United States
- Henderson, Nevada, United States
- Reno, Nevada, United States
- Voorhees Township, New Jersey, United States
- Loveland, Ohio, United States
- Chadds Ford, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Jupiter, Florida, United States; Slidell, Louisiana, United States; Oxon Hill, Maryland, United States; Henderson, Nevada, United States; Reno, Nevada, United States; Voorhees Township, New Jersey, United States and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.