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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Zyga Technology, Inc.
Sponsor:
Information provided by (Responsible Party):
Zyga Technology, Inc.
ClinicalTrials.gov Identifier:
NCT02179476
First received: January 28, 2013
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

A non-randomized, multi-site feasibility study to evaluate the safety of the Glyder Device in subjects with documented single level lumbar facet joint pain from L2 to sacrum.


Condition Intervention Phase
Facet Joint Pain
Device: Glyder
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Site Study of the Zyga GlyDer Facet Restoration Device In Subjects With LUmbar FacET Pain Syndrome (DUET)

Further study details as provided by Zyga Technology, Inc.:

Primary Outcome Measures:
  • Primary Safety Endpoint [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by assessing the incidence of device and/or procedure related serious adverse events.


Secondary Outcome Measures:
  • Safety Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by assessing the incidence of device and/or procedure related serious adverse events.


Estimated Enrollment: 20
Study Start Date: June 2014
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glyder
Glyder Facet Restoration Device
Device: Glyder
The Glyder Facet Restoration Device is intended for minimally invasive bilateral implantation at a single lumbar facet level
Other Names:
  • Glyder Facet Restoration Device
  • Glyder Device

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Single level symptomatic facet joint disease from L2 to the sacrum
  2. Two diagnostic injections confirming facet joint pain
  3. VAS Back of ≥ 60 mm on a 100 mm scale, and VAS Back is greater than or equal to the highest VAS Leg score
  4. ODI ≥ 20 points
  5. Failure to respond to 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)
  6. At least 22 years of age and skeletally mature

Key Exclusion Criteria:

  1. Grade 3 joint osteoarthritis (Weishaupt scale)
  2. Osteoporosis or severe osteopenia
  3. Marked lumbar instability on resting lateral or flexion-extension radiographs
  4. Absence of facet motion at the index level
  5. Symptomatic spinal stenosis requiring surgical intervention
  6. Disc herniation requiring surgical intervention
  7. Prior total disc replacement, fusion, decompressive laminectomy, facetectomy, or placement of a posterior spinous process device
  8. The subject has a Body Mass Index (BMI) of greater than 35
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02179476

Contacts
Contact: Lisa Ingham 952-698-9958 lingham@zyga.com

Locations
United States, Colorado
Rocky Mountain Associates in Orthopedic Medicine Recruiting
Johnstown, Colorado, United States, 80534
Contact: Kira    970-669-8881 ext 229      
Principal Investigator: Kenneth Pettine, MD         
United States, Maryland
Greater Baltimore Neurological Associates Recruiting
Baltimore, Maryland, United States, 21204
Contact: Stephanie    443-849-4282      
Principal Investigator: Reginald Davis, MD         
United States, Nevada
Western Regional Center for Brain and Spine Surgery Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Helen    702-737-1948      
Principal Investigator: William Smith         
United States, North Carolina
Carolina Neurosurgery and Spine Associates Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Susan Lydon    800-344-6716      
Principal Investigator: Domagoj Coric, MD         
United States, Oklahoma
Clinical Radiology of Oklahoma Recruiting
Edmond, Oklahoma, United States, 73083
Contact: Jennifer    405-601-2325      
Principal Investigator: Douglas Beall, MD         
Sponsors and Collaborators
Zyga Technology, Inc.
  More Information

No publications provided

Responsible Party: Zyga Technology, Inc.
ClinicalTrials.gov Identifier: NCT02179476     History of Changes
Other Study ID Numbers: DUET 001-003
Study First Received: January 28, 2013
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Zyga Technology, Inc.:
Facet joint
facet joint pain
facet joint disease
lumbar pain
back pain

Additional relevant MeSH terms:
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014