Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The zLOCK Facet Stabilization System is a fixation device intended to provide posterior stability in the lumbar spine fusion procedure. The system can be placed either as an adjunct to an inter-vertebral anterior cage or as stand-alone with/ without additional decompression of the dural sac or nerve roots as appropriate for the specific patient and surgeon's discretion. The zLOCK implant is placed inside the facet to stabilize the motion and enhance the bony fusion of the joint. The zLOCK Facet Stabilization System is intended for single-level stabilization of a spinal motion segment in order to promote bony fusion of the joint. The zLOCK system is indicated for use from L1-L2 to L5-S1 joints.
The zLOCK implant is inserted into the facet joint space while adapting to the joint's changing geometry. Stabilization is achieved by a firm grip of each joint bone and resisting any relative motion. The zLOCK implant is placed percutaneously and requires only one incision per side, thereby reducing the invasiveness procedure duration and shortening the recovery period.
This pivotal study was designed in order to assess the safety and effectiveness of the zLOCK system.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zLock Facet Locking Implant System | Experimental | Device: zLOCK Facet Stabilization System zLOCK Facet Stabilization System is a device intended to provide posterior stability in lumbar spine in order to reduce lumbar back pains |
|
| 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 |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events as assessed by paucity of device related reoperation | The safety of the zLOCK Facet Implant System will be established based on the paucity of device-related reoperations. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain level measured by Visual Analog Score for pain | The efficacy assessment of the ZygoFix Facet stabilization System will be established by change in pain level . | 1 year |
Not provided
Inclusion Criteria:
Patient is scheduled for spine surgery with at least one of the following:
When used stand-alone disc height should be maximum 50% of the adjacent disc height.
18< Age <75
Weight < 100Kg
Signed informed consent form
At least 3 months of unsuccessful conventional treatments
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanna Levy, Dr. | Contact | +972522824966 | hanna@qsitemed.com |
| Name | Affiliation | Role |
|---|---|---|
| Hanna Levy, Dr. | ZygoFix | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedizinischenFakultät der Universität Rostock | Recruiting | Rostock | 18055 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| AOU Policlinico "Paolo Giaccone" | Recruiting | Palermo | Italy |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D020763 | Pathological Conditions, Anatomical |