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ZygoFix has developed a system consisting of zLOCK Facet Fusion System. The zLOCK Facet Fusion System is intended for single level stabilization of a spinal motion segment to promote bonny fusion of the joint. The system is designed for percutaneous deployment. The zLOCK implant is designed to be deployed in the facet joint thereby utilizing the body's natural mechanical structure without adding an external scaffold (see figure below).
The zLOCK implant is inserted into the facet joint space while it adapts to the joint's changing geometry. Stabilization is achieved by firm grip of each joint bone and resisting to any relative motion. The zLOCK implant is placed percutaneously and requires only one incision per side, thereby reducing the invasiveness, procedure duration and shorten the recovery period.
This pilot study was designed in order to assess the safety and effectiveness of the zLOCK system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zLock Facet Locking Implant System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zLOCK Facet Stabilization System | Device | zLOCK Facet Stabilization System is a device intended to provide posterior stability in lumbar spine in order to reduce lumbar back pains |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment - no device related reoperation | The safety of the zLOCK Facet Implant System will be established based on the absence of device related reoperations. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy assessment - achieving facet fusion 12 months post procedure | The efficacy of using the zLOCK System will be determined by achieving facet fusion 12 months post procedure. Patient is defined "success" if facet fusion is achieved at 12 months post procedure. | 12 months |
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Inclusion Criteria:
Patient is scheduled for spine surgery with at least one of the following:
When used in adjunct to an intervertebral front cage:
When used stand-alone:
Claudication due to moderate to severe stenosis (central/ foraminal) as verified by imaging.
18< Age < 75
Weight < 100Kg
Signed informed consent form
At least 3 months of unsuccessful conventional treatments
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanna Levy, Dr | ZygoFix | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pecs University Hospital | Pécs | H-7623 | Hungary |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D013168 | Spondylolisthesis |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D020763 | Pathological Conditions, Anatomical |