REFINE Study: Aurora Spine ZIP™ MIS Interspinous Fusion System for Low Back Pain
This study, called REFINE, is looking at how well and how safely a device called the Aurora Spine ZIP™ MIS Interspinous Fusion System works. It's for adults aged 18 or older who have ongoing low back pain from degenerative disc disease (wear and tear of the spinal discs) and a condition called neurogenic claudication (leg pain or numbness that gets better when you bend forward). The study will also use bone graft material with the device. Researchers will measure pain reduction while standing at 3 and 12 months to see if the treatment is effective. The study aims to enroll 100 participants, but its current status is unclear.
- Study design
- This is an interventional study planning to enroll 100 participants. It will evaluate the Aurora Spine ZIP™ MIS Interspinous Fusion System.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 12 months after treatment to assess pain reduction.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
REFINE Study: A Study In a Novel Interspinous Fusion Device In Subjects With Low Back Pain
At a glance
Conditions
Where it's being run
10 sites across 8 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- To evaluate the efficacy and safety of the Aurora Spine ZIP™ MIS Interspinous Fusion System and bone graft material based on improvement in composite endpoints relative to baseline at 3 and 12 months 1. > 20mm pain reduction in VAS Back while standing12 months
The primary composite endpoint is individual patient success from baseline at 3- and 12-months of follow-up, which will be assessed as follows: 1. \> 20mm pain reduction in VAS Back while standing or walking 2. \> 20mm pain reduction in VAS Leg while standing or walking 3. Zurich Claudication Questionnaire improvement of 0.5 or greater in 2 or 3 domains) 4. ODI improvement of ≥ 10pts 5. No reoperations or revisions at the index level (s)