A non-randomized, multi-site feasibility study to evaluate the safety of the Glyder Device in subjects with a history of lumbar facet joint disease (L2 to the sacrum) and successful neural ablation in which the facet joint is confirmed as the source of pain.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
The Glyder Facet Restoration Device is intended for minimally invasive bilateral implantation in one or two lumbar facet levels
The Spine Institute
Santa Monica, California, United States
Laser Spine Institute
Tampa, Florida, United States
Clinical Radiology of Oklahoma
Edmond, Oklahoma, United States
Northwest Orthopaedic Specialists
Spokane, Washington, United States
Primary Safety Endpoint
Safety will be evaluated by assessing the incidence of device and/or procedure related serious adverse events.
Time frame: 6 months
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