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

October 10, 2018 updated by: Zyga Technology, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90403
        • The Spine Institute
    • Florida
      • Tampa, Florida, United States, 33607
        • Laser Spine Institute
    • Oklahoma
      • Edmond, Oklahoma, United States, 73083
        • Clinical Radiology of Oklahoma
    • Washington
      • Spokane, Washington, United States, 99208
        • Northwest Orthopaedic Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Glyder
Glyder Facet Restoration Device
Device: Glyder
The Glyder Facet Restoration Device is intended for minimally invasive bilateral implantation in one or two lumbar facet levels
Other Names:
  • Glyder Facet Restoration Device
  • Glyder Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Safety Endpoint
Time Frame: 6 months
Safety will be evaluated by assessing the incidence of device and/or procedure related serious adverse events.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zyga Technology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

September 1, 2018

Study Registration Dates

First Submitted

January 28, 2013

First Submitted That Met QC Criteria

June 30, 2014

First Posted (ESTIMATE)

July 1, 2014

Study Record Updates

Last Update Posted (ACTUAL)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DUET 001-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Facet Joint Pain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe