Last updated: February 6, 2024
Sponsor: ZygoFix
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
zLOCK Facet Stabilization System
Clinical Study ID
NCT05266521
DMS
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 ornot possible to place.
- Any entity or conditions that totally preclude the possibility of fusion, i.e. canceror 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 bytest in case of woman of child-bearing potential that do not practice medicallyacceptable methods of contraception)
- Concurrent participation in another clinical trial using any investigational drug ordevice.
- Mental disorders.
- Tumor
- Fracture or other instabilities of the posterior elements.
Study Design
Total Participants: 80
Treatment Group(s): 1
Primary Treatment: zLOCK Facet Stabilization System
Phase:
Study Start date:
November 07, 2021
Estimated Completion Date:
September 30, 2025
Connect with a study center
MedizinischenFakultät der Universität Rostock
Rostock, 18055
GermanyActive - Recruiting
AOU Policlinico "Paolo Giaccone"
Palermo,
ItalyActive - Recruiting
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