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

Zyga Technology

Status

Terminated

Conditions

Facet Joint Pain

Treatments

Device: Glyder

Study type

Interventional

Funder types

Industry

Identifiers

NCT02179476

DUET 001-003

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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