Clinical Evidence for the Surgical Treatment of Facet Degeneration
GLISSADE Study The GLISSADE Study was a prospective, 40-patient trial that studied the Glyder® Facet Restoration System in the treatment of chronic facetogenic pain due to facet degeneration or mechanical facet joint disease.
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. 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.
- Of 40 enrolled patients, 37 patients received the Glyder Facet Restoration Device and 34 patients completed 1-year follow-up. 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.
Click here to learn more about the Glyder Facet Restoration procedure and how it may benefit those suffering from facet degeneration.
Clinical studies of the device are ongoing
The Glyder Facet Restoration Device is intended to provide relief from lumbar facet joint pain and disability, restoring facet joint function while preserving native anatomy. The Glyder device is designed for bilateral implantation in painful lumbar facet joints from L2 to the sacrum, in patients experiencing:
- Degenerative facet joint disease (e.g. osteoarthritis, post-traumatic arthritis, facet degeneration due to intervertebral disc height reduction)
- Mechanical joint disease (e.g. synovial impingement, meniscoid entrapment)
Patients considered for the Glyder Facet Restoration procedure should exhibit facet degeneration of 0 to 2 on the Weishaupt scale. For a complete list of indications, contraindications, warnings and precautions please review the Instructions for Use.
Patients receiving the Glyder device experienced back pain reduction of 41% (p>0.001) with therapeutic benefit maintained at 12 months.1
Click here to learn more about patient selection and diagnosis of facet joint disease.
CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use