BACKGROUND: The zygapophysial (facet) joint is the primary @entity158 generator in one third of chronic @entity1643 cases. Current treatment options include temporarily palliative nonsurgical approaches, facet injections, radiofrequency denervation, and, rarely, lumbar arthrodesis. The purpose of this study was to assess the safety and effectiveness of a minimally invasive implant intended to restore facet joint function in @entity1 with @entity1118 . METHODS: This prospective, multi-center feasibility study enrolled @entity1 with @entity158 at 1 or 2 levels who underwent at least 6  months of unsuccessful nonoperative care. @entity1 received a minimally invasive implant (Glyder   Facet Restoration Device, Zyga Technology, Inc., Minnetonka, MN) intended to restore facet joint function while preserving the native anatomy. Main outcomes included @entity615 severity using a visual analogue scale, back-specific disability using the Oswestry Disability Index (ODI), and adverse events adjudicated by an independent Clinical Events Committee. RESULTS: Of 40 enrolled @entity1 , 37 @entity1 received the facet restoration implant and 34 @entity1 had complete 1-year follow-up data available. Over the 1-year follow-up period, @entity615 severity decreased 41% and ODI decreased 34%, on average. Freedom from a device- or procedure-related serious adverse event through 1  year was 84%. Implant migration was observed in 3 @entity1 and implant expulsion from the facet joint occurred in 3 @entity1 . In total, 2 (5.4%) @entity1 underwent implant removal through 1  year post-treatment. CONCLUSIONS: A minimally invasive facet restoration implant is a promising treatment option in select @entity1 with chronic lumbar zygapophysial @entity158 who have exhausted nonsurgical treatments, with therapeutic benefit persisting at 1  year follow-up.

Minimally invasive facet restoration implant for chronic lumbar zygapophysial XXXX : 1-year outcomes.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity1643 :: ('MESH:D017116', 'Disease') :: ['low back pain'] @entity615 :: ('MESH:D001416', 'Disease') :: ['back pain'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain', 'confirmed lumbar facetogenic joint pain'] @entity1118 :: ('MESH:D059350', 'Disease') :: ['chronic lumbar facetogenic pain']
@entity158 :: (MESH:D010146,Disease) :: ['pain']
