Safety And Efficacy Assessment of the zLock Facet Fusion System- A Pilot Study (NCT04229316) | Clinical Trial Compass
CompletedNot Applicable
Safety And Efficacy Assessment of the zLock Facet Fusion System- A Pilot Study
Hungary24 participantsStarted 2018-04-12
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient is scheduled for spine surgery with at least one of the following:
✓. 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
✕. Fusion procedure performed or required in more than one inter-vertebrae space.
✕. Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation.
✕. Osteoporosis
✕. 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.
✕. Any entity or conditions that totally preclude the possibility of fusion, i.e., cancer, kidney dialysis, or osteopenia, are relative contraindications.