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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02179476

Acronym

DUET

Enrollment

Registered

2014-07-01

Start date

2014-06-30

Completion date

2018-09-30

Last updated

2018-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facet Joint Pain

Keywords

Facet joint, facet joint pain, facet joint disease, lumbar pain, back pain

Brief 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.

Interventions

DEVICEGlyder

The Glyder Facet Restoration Device is intended for minimally invasive bilateral implantation in one or two lumbar facet levels

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: 1. Confirmed bilateral facet joint disease demonstrated by a successful facet rhizotomy (neural ablation) within 18 months prior to enrollment 2. Facet pain is limited to one to two levels from L2 to the sacrum and pain is bilateral 3. Two diagnostic injections (MBBs) both resulting in 80% relief to confirm back pain is facetogenic 4. 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 5. ODI ≥ 20 points 6. 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) 7. At least 22 years of age and skeletally mature Key

Exclusion criteria

1. Pain is from a spinal structure other than facet joints (i.e., disc, hip and SI joint pain are excluded) 2. Osteoporosis or severe osteopenia 3. Lumbar fusion 4. Symptomatic spinal stenosis requiring surgical intervention 5. Prior total disc replacement, fusion, decompressive laminectomy, facetectomy, or placement of a posterior spinous process device 6. Disc herniation requiring surgical intervention 7. The subject has a Body Mass Index (BMI) of greater than 35 8. Planned elective surgery within 12 months

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026