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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-09-30

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.

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Detailed Description

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Conditions

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Facet Joint Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glyder

Glyder Facet Restoration Device

Group Type EXPERIMENTAL

Glyder

Intervention Type DEVICE

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

Interventions

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Glyder

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

Intervention Type DEVICE

Other Intervention Names

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Glyder Facet Restoration Device Glyder Device

Eligibility Criteria

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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

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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No