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

Facet Joint Pain Clinical Trial

— DUET  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02179476
• Other study ID #: DUET 001-003
• Status: Terminated
• Phase: N/A
• Start date: June 2014
• Est. completion date: September 2018

Study information

• Verified date: October 2018
• Source: Zyga Technology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Facet Joint Pain

Intervention

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

Locations

Country	Name	City	State
United States	Clinical Radiology of Oklahoma	Edmond	Oklahoma
United States	The Spine Institute	Santa Monica	California
United States	Northwest Orthopaedic Specialists	Spokane	Washington
United States	Laser Spine Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Zyga Technology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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