Safety and Efficacy Assessment of Using the zLOCK Facet Stabilization System (NCT05266521) | Clinical Trial Compass
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Safety and Efficacy Assessment of Using the zLOCK Facet Stabilization System
Germany, Italy80 participantsStarted 2021-11-07
Plain-language summary
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.
Who can participate
Age range18 Years ā 75 Years
SexALL
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Inclusion criteria
ā. Patient is scheduled for spine surgery with at least one of the following:
ā. When used stand-alone disc height should be maximum 50% of the adjacent disc height.
ā. 18\< Age \<75
ā. Weight \< 100Kg
ā. Signed informed consent form
ā. At least 3 months of unsuccessful conventional treatments
Exclusion criteria
ā. Fusion procedure performed or required in more than one motion segment.
ā. Acute or chronic spinal infections.
ā. Osteoporosis when used in adjunct to an anterior interbody cage (DEXA \< -2.5).
ā. Absence of posterior spinal elements including the pedicle, pars interarticularis, facet joints, spinous process and the majority of the lamina which make it unstable or not possible to place.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events as assessed by paucity of device related reoperation