Safety and Efficacy Assessment of Using the zLOCK Facet Stabilization System

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-vertebral anterior cage or as stand-alone with/ without additional decompression of the dural sac or nerve roots as appropriate for the specific patient and surgeon's discretion. The zLOCK implant is placed inside the facet to stabilize the motion and enhance the bony fusion of the joint. The zLOCK Facet Stabilization System is intended for single-level stabilization of a spinal motion segment in order to promote bony fusion of the joint. The zLOCK system is indicated for use from L1-L2 to L5-S1 joints.

The zLOCK implant is inserted into the facet joint space while adapting to the joint's changing geometry. Stabilization is achieved by a firm grip of each joint bone and resisting any relative motion. The zLOCK implant is placed percutaneously and requires only one incision per side, thereby reducing the invasiveness procedure duration and shortening the recovery period.

This pivotal study was designed in order to assess the safety and effectiveness of the zLOCK system.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Device: zLOCK Facet Stabilization System

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hanna Levy, Dr.; Phone Number: +972522824966; Email: hanna@qsitemed.com

Study Locations

• Germany
  • Rostock, Germany, 18055
    • Recruiting
    • MedizinischenFakultät der Universität Rostock
    • Contact: Hanna Levy, Dr.; Phone Number: +972522824966; Email: hanna@qsitemed.com
• Italy
  • Palermo, Italy
    • Recruiting
    • AOU Policlinico "Paolo Giaccone"
    • Contact: Fabio Torregrossa, M.D.; Email: giovanni.grasso@unipa.it
    • Principal Investigator: Giovanni Grasso, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: zLock Facet Locking Implant System; Device: zLOCK Facet Stabilization System zLOCK Facet Stabilization System is a device intended to provide posterior stability in lumbar spine in order to reduce lumbar back pains	Device: zLOCK Facet Stabilization 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
Incidence of Treatment-Emergent Adverse Events as assessed by paucity of device related reoperation	The safety of the zLOCK Facet Implant System will be established based on the paucity of device-related reoperations.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain level measured by Visual Analog Score for pain	The efficacy assessment of the ZygoFix Facet stabilization System will be established by change in pain level .	1 year

Collaborators and Investigators

• Sponsor: ZygoFix
• Investigators: Study Director: Hanna Levy, Dr., ZygoFix

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2021
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: February 13, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Stenosis; Spondylolisthesis; Stabilization; Facet arthritis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: DMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No