Aurora Spine reported a 63% clinical success rate at 12 months in a study evaluating its ZIP MIS Interlaminar Fusion System in patients with lumbar spinal stenosis and degenerative disc disease.
The findings were published Oct. 9 in the International Journal of Spine Surgery. The prospective, multicenter REFINE study included 94 patients who underwent implantation, with 79 completing 12-month follow-up.
Among patients with evaluable follow-up data, 50 of 79 met the study’s composite clinical success endpoint, which included improvements in pain, disability and disease-specific function without reoperation or revision at the treated level. Mean disability scores improved by 22.0 points, while back and leg pain scores improved by 35.7 and 36.5 points, respectively.
Additionally, 83% of patients reported at least minimal improvement, while 66% reported being much or very much improved. Researchers reported six adverse events, including three related to the device or procedure. No device explants, reoperations at the treated level or symptomatic spinous process fractures were reported at 12 months.
The study was funded by Aurora Spine. Its single-arm, nonrandomized design lacked a comparison group, limiting conclusions about the device’s effectiveness relative to other treatments.
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