Safety And Efficacy Assessment of the zLock Facet Fusion System- A Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Pecs, Hungary, H-7623
- Pecs University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patient is scheduled for spine surgery with at least one of the following:
When used in adjunct to an intervertebral front cage:
- Degenerative Spondylolisthesis up to grade 2
- Mild to Moderate Degenerative disc disease (DDD)
- Degeneration of the facets - following validating the pain source by facet injection.
When used stand-alone:
- Degenerative Spondylolisthesis grade 1-2
- Moderate to severe Stenosis with listhesis
- Moderate to severe stenosis without listhesis (in cases that the investigator determines stabilization is required).
- Degeneration of the facets- following validating the pain source by facet injection.
- 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.
- Obesity (BMI ≥30)
- Foreign body sensitivity
- Alcoholism, or drug abuse
- Subject with a cardiac pacemaker or other implanted electro medical device
- Subject with known condition of drug abuse and/or alcoholism
- Women who are either pregnant or nursing at the time of screening (to be verified by test in case of woman of child-bearing potential that do not practice medically acceptable methods of contraception)
- Concurrent participation in another clinical trial using any investigational drug or device.
- Mental disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: zLock Facet Locking Implant System
|
zLOCK Facet Stabilization System is a device intended to provide posterior stability in lumbar spine in order to reduce lumbar back pains
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety assessment - no device related reoperation
Time Frame: 3 months
|
The safety of the zLOCK Facet Implant System will be established based on the absence of device related reoperations.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy assessment - achieving facet fusion 12 months post procedure
Time Frame: 12 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hanna Levy, Dr, ZygoFix
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMS-3343
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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