Hans-Jörg Meisel1, Konrad Seller2, Achim L Th2, Karin B Ttner-Janz3, Peter Stosberg1, Alexander Moser4, Larry E Miller5, Jon E Block6, Luiz Pimenta7. 1. Center of Neurosciences, Department of Neurosurgery, BG-Clinic Bergmannstrost, Merseburger Strasse 165, Halle, Germany. 2. Spine Center Freiburg, Hornus Str. 18, Freiburg, D-79108, Germany. 3. Büttner-Janz Spinefoundation, Meinekestr. 6, Berlin, 10719, Germany. 4. Vivantes Klinikum, Landsberger Allee 49, Berlin, 10249, Germany. 5. Miller Scientific Consulting, Inc, 1854 Hendersonville Road, #231, Asheville 28803, NC, USA ; The Jon Block Group, 2210 Jackson Street, Suite 401, San Francisco 94115, CA, USA. 6. The Jon Block Group, 2210 Jackson Street, Suite 401, San Francisco 94115, CA, USA. 7. Instituto de Patologia da Caluna, Rua Vergueiro 1421-Sala 305, Sao Paulo, Brazil.
Abstract
BACKGROUND: The zygapophysial (facet) joint is the primary pain generator in one third of chronic low back pain 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 patients with chronic lumbar facetogenic pain. METHODS: This prospective, multi-center feasibility study enrolled patients with confirmed lumbar facetogenic joint pain at 1 or 2 levels who underwent at least 6 months of unsuccessful nonoperative care. Patients 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 back pain 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 patients, 37 patients received the facet restoration implant and 34 patients had complete 1-year follow-up data available. Over the 1-year follow-up period, back pain 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 patients and implant expulsion from the facet joint occurred in 3 patients. In total, 2 (5.4%) patients underwent implant removal through 1 year post-treatment. CONCLUSIONS: A minimally invasive facet restoration implant is a promising treatment option in select patients with chronic lumbar zygapophysial pain who have exhausted nonsurgical treatments, with therapeutic benefit persisting at 1 year follow-up.
BACKGROUND: The zygapophysial (facet) joint is the primary pain generator in one third of chronic low back pain 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 patients with chronic lumbar facetogenic pain. METHODS: This prospective, multi-center feasibility study enrolled patients with confirmed lumbar facetogenic joint pain at 1 or 2 levels who underwent at least 6 months of unsuccessful nonoperative care. Patients 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 back pain 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 patients, 37 patients received the facet restoration implant and 34 patients had complete 1-year follow-up data available. Over the 1-year follow-up period, back pain 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 patients and implant expulsion from the facet joint occurred in 3 patients. In total, 2 (5.4%) patients underwent implant removal through 1 year post-treatment. CONCLUSIONS: A minimally invasive facet restoration implant is a promising treatment option in select patients with chronic lumbar zygapophysial pain who have exhausted nonsurgical treatments, with therapeutic benefit persisting at 1 year follow-up.
Authors: Allyson Ianuzzi; Jesse S Little; Jonathan B Chiu; Avi Baitner; Greg Kawchuk; Partap S Khalsa Journal: Spine J Date: 2004 Mar-Apr Impact factor: 4.166