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

Primary Purpose

Facet Joint Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Glyder
Sponsored by
Zyga Technology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Facet Joint Pain focused on measuring Facet joint, facet joint pain, facet joint disease, lumbar pain, back pain

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Spine Institute
  • Laser Spine Institute
  • Clinical Radiology of Oklahoma
  • Northwest Orthopaedic Specialists

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Glyder

Arm Description

Glyder Facet Restoration Device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 28, 2013
Last Updated
October 10, 2018
Sponsor
Zyga Technology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02179476
Brief Title
A Multi-Site Study of the Zyga GlyDer Facet Restoration Device In Subjects With LUmbar FacET Pain Syndrome - DUET
Acronym
DUET
Official Title
A Multi-Site Study of the Zyga GlyDer Facet Restoration Device In Subjects With LUmbar FacET Pain Syndrome (DUET)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
No additional enrollment
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zyga Technology, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facet Joint Pain
Keywords
Facet joint, facet joint pain, facet joint disease, lumbar pain, back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glyder
Arm Type
Experimental
Arm Description
Glyder Facet Restoration Device
Intervention Type
Device
Intervention Name(s)
Glyder
Other Intervention Name(s)
Glyder Facet Restoration Device, Glyder Device
Intervention Description
The Glyder Facet Restoration Device is intended for minimally invasive bilateral implantation in one or two lumbar facet levels
Primary Outcome Measure Information:
Title
Primary Safety Endpoint
Description
Safety will be evaluated by assessing the incidence of device and/or procedure related serious adverse events.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
The Spine Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Laser Spine Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Clinical Radiology of Oklahoma
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73083
Country
United States
Facility Name
Northwest Orthopaedic Specialists
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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