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

Not Applicable

Terminated

• Conditions: Facet Joint Pain
• Interventions: Device: Glyder

• Registration Number: NCT02179476
• Lead Sponsor: Zyga Technology, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-28
• Study Start: 2014-06
• Study First Submitted QC: 2014-06-30
• Study First Posted: 2014-07-01
• Primary Completion: 2017-12
• Study Completion: 2018-09
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glyder	Glyder	Glyder Facet Restoration Device

Primary Outcome Measures

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

Trial Locations

Locations (4)

Laser Spine Institute; 🇺🇸 Tampa, Florida, United States

The Spine Institute; 🇺🇸 Santa Monica, California, United States

Clinical Radiology of Oklahoma; 🇺🇸 Edmond, Oklahoma, United States

Northwest Orthopaedic Specialists; 🇺🇸 Spokane, Washington, United States