Status:
RECRUITING
Safety and Efficacy Assessment of Using the zLOCK Facet Stabilization System
Lead Sponsor:
ZygoFix
Conditions:
Low Back Pain
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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-verteb...
Eligibility Criteria
Inclusion
- Patient is scheduled for spine surgery with at least one of the following:
- Degenerative Spondylolisthesis grade 1;
- Mild to Moderate stenosis;
- Degeneration of the facets.
- 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
- Fusion procedure performed or required in more than one motion segment.
- Acute or chronic spinal infections.
- Osteoporosis when used in adjunct to an anterior interbody cage (DEXA \< -2.5).
- 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 or kidney dialysis.
- Obesity (BMI ≥30)
- Unilateral application of device, except in combination with anterior interbody cages.
- Known sensitivity to Titanium.
- Alcoholism, or drug abuse
- Subject with a cardiac pacemaker or other implanted electro medical device
- 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.
- Tumor
- Fracture or other instabilities of the posterior elements.
Key Trial Info
Start Date :
November 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05266521
Start Date
November 7 2021
End Date
September 30 2025
Last Update
February 7 2024
Active Locations (2)
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1
MedizinischenFakultät der Universität Rostock
Rostock, Germany, 18055
2
AOU Policlinico "Paolo Giaccone"
Palermo, Italy