A Multi-Site Study of the Zyga GlyDer Facet Restoration Device In Subjects With LUmbar FacET Pain… (NCT02179476) | Clinical Trial Compass
TerminatedNot Applicable
A Multi-Site Study of the Zyga GlyDer Facet Restoration Device In Subjects With LUmbar FacET Pain Syndrome - DUET
Stopped: No additional enrollment
United States2 participantsStarted 2014-06
Plain-language summary
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.
Who can participate
Age range22 Years
SexALL
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Inclusion criteria
✓. Confirmed bilateral facet joint disease demonstrated by a successful facet rhizotomy (neural ablation) within 18 months prior to enrollment
✓. Facet pain is limited to one to two levels from L2 to the sacrum and pain is bilateral
✓. Two diagnostic injections (MBBs) both resulting in 80% relief to confirm back pain is facetogenic
✓. VAS back pain of ≥ 60 mm on a 100 mm scale, and VAS back pain is greater than or equal to the highest VAS leg pain score
✓. ODI ≥ 20 points
✓. At least six (6) months of non-operative conservative management (Analgesic therapy for a minimum of 2 weeks and a minimum of 4 weeks of NSAID therapy; Supervised exercise and/or physical therapy program-minimum of 12 sessions)
✓. At least 22 years of age and skeletally mature
Exclusion criteria
✕. Pain is from a spinal structure other than facet joints (i.e., disc, hip and SI joint pain are excluded)