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

NCT02179476 | Terminated DMC

• 1 other identifier: DUET 001-003
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 4

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.

Conditions

Facet Joint Pain

Keywords

Facet joint; facet joint pain; facet joint disease; lumbar pain; back pain

Outcome Measures

Primary Outcomes (1)

• Primary Safety Endpoint

  Safety will be evaluated by assessing the incidence of device and/or procedure related serious adverse events.

  6 months

Study Arms (1)

Glyder

EXPERIMENTAL

Glyder Facet Restoration Device

Device: Glyder

Interventions

Glyder DEVICE

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

Also known as: Glyder Facet Restoration Device, Glyder Device

Glyder

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zyga Technology, Inc.: lead

Study Sites (4)

The Spine Institute

Santa Monica, California, 90403, United States

Location

Laser Spine Institute

Tampa, Florida, 33607, United States

Location

Clinical Radiology of Oklahoma

Edmond, Oklahoma, 73083, United States

Location

Northwest Orthopaedic Specialists

Spokane, Washington, 99208, United States

Location

MeSH Terms

Conditions

Low Back Pain; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: July 1, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: September 1, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

US (4)