A Multi-Site Study of the Zyga GlyDer Facet Restoration Device In Subjects With LUmbar FacET Pain Syndrome - DUET

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Site Study of the Zyga GlyDer Facet Restoration Device In Subjects With LUmbar FacET Pain Syndrome (DUET)

Conditions
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Facet Joint Pain

Intervention / Treatment
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* Device: Glyder


Participation Criteria
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Eligibility Criteria
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Key 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 Key Exclusion Criteria: Pain is from a spinal structure other than facet joints (i.e., disc, hip and SI joint pain are excluded) Osteoporosis or severe osteopenia Lumbar fusion Symptomatic spinal stenosis requiring surgical intervention Prior total disc replacement, fusion, decompressive laminectomy, facetectomy, or placement of a posterior spinous process device Disc herniation requiring surgical intervention The subject has a Body Mass Index (BMI) of greater than 35 Planned elective surgery within 12 months

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glyder<br>Glyder Facet Restoration Device | Device: Glyder<br>* The Glyder Facet Restoration Device is intended for minimally invasive bilateral implantation in one or two lumbar facet levels<br>* Other names: Glyder Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint | Safety will be evaluated by assessing the incidence of device and/or procedure related serious adverse events. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Facet joint, facet joint pain, facet joint disease, lumbar pain, back pain