Safety and Efficacy Assessment of Using the zLOCK Facet Stabilization System

Launched by ZYGOFIX · Feb 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the zLOCK Facet Stabilization System, which is designed to help stabilize the lower back during surgery for conditions like low back pain. The zLOCK device is placed in the facet joint of the spine, helping to keep the bones in place and promote healing after surgery. It can be used alone or alongside other treatments and is intended for specific areas in the lower spine. The goal of this trial is to determine how safe and effective the zLOCK system is for patients undergoing spine surgery.

To participate in this study, individuals must be between 18 and 75 years old and have certain back issues, such as mild to moderate spinal stenosis or degeneration of the facet joints. They should have tried other treatments for at least three months without success. Participants can expect to undergo a less invasive procedure, which involves a smaller incision and a potentially shorter recovery time. It’s important to note that there are some criteria that would exclude people from joining, such as having certain infections, being significantly overweight, or having other serious medical conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. 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.
• • 2. When used stand-alone disc height should be maximum 50% of the adjacent disc height.
• • 3. 18\< Age \<75
• • 4. Weight \< 100Kg
• • 5. Signed informed consent form
• • 6. At least 3 months of unsuccessful conventional treatments
• Exclusion Criteria:
• • 1. Fusion procedure performed or required in more than one motion segment.
• • 2. Acute or chronic spinal infections.
• • 3. Osteoporosis when used in adjunct to an anterior interbody cage (DEXA \< -2.5).
• • 4. 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.
• • 5. Any entity or conditions that totally preclude the possibility of fusion, i.e. cancer or kidney dialysis.
• • 6. Obesity (BMI ≥30)
• • 7. Unilateral application of device, except in combination with anterior interbody cages.
• • 8. Known sensitivity to Titanium.
• • 9. Alcoholism, or drug abuse
• • 10. Subject with a cardiac pacemaker or other implanted electro medical device
• • 11. 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)
• • 12. Concurrent participation in another clinical trial using any investigational drug or device.
• • 13. Mental disorders.
• • 14. Tumor
• • 15. Fracture or other instabilities of the posterior elements.