Facet Joint Pain Clinical Trial
— DUETOfficial title:
A Multi-Site Study of the Zyga GlyDer Facet Restoration Device In Subjects With LUmbar FacET Pain Syndrome (DUET)
NCT number | NCT02179476 |
Other study ID # | DUET 001-003 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2014 |
Est. completion date | September 2018 |
Verified date | October 2018 |
Source | Zyga Technology, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Zyga Technology, Inc. |
United States,
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 |
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