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: Active, not recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Device: zLOCK Facet Stabilization System

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Pecs, Hungary, H-7623
    • Pecs University Hospital

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:

   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.
2. Claudication due to moderate to severe stenosis (central/ foraminal) as verified by imaging.
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 inter-vertebrae space.
2. Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation.
3. Osteoporosis
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, kidney dialysis, or osteopenia, are relative contraindications.
6. Obesity (BMI ≥30)
7. Foreign body sensitivity
8. Alcoholism, or drug abuse
9. Subject with a cardiac pacemaker or other implanted electro medical device
10. Subject with known condition of drug abuse and/or alcoholism
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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessment - no device related reoperation	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	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: ZygoFix
• Investigators: Study Director: Hanna Levy, Dr, ZygoFix

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2018
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 18, 2020

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: stabilization, facet arthritis, spondylolisthesis, stenosis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: DMS-3343

Drug and device information, study documents

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