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Safety And Efficacy Assessment of the zLock Facet Fusion System- A Pilot Study

Primary Purpose

Low Back Pain

Status

Active

Phase

Not Applicable

Locations

Hungary

Study Type

Interventional

Intervention

zLOCK Facet Stabilization System

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring stabilization, facet arthritis, spondylolisthesis, stenosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Claudication due to moderate to severe stenosis (central/ foraminal) as verified by imaging.
18< Age < 75
Weight < 100Kg
Signed informed consent form
At least 3 months of unsuccessful conventional treatments

Exclusion Criteria:

Fusion procedure performed or required in more than one inter-vertebrae space.
Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation.
Osteoporosis
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, kidney dialysis, or osteopenia, are relative contraindications.
Obesity (BMI ≥30)
Foreign body sensitivity
Alcoholism, or drug abuse
Subject with a cardiac pacemaker or other implanted electro medical device
Subject with known condition of drug abuse and/or alcoholism
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.

Sites / Locations

Pecs University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

zLock Facet Locking Implant System

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04229316

First Posted

January 8, 2020

Last Updated

July 12, 2023

Sponsor

ZygoFix

1. Study Identification

Unique Protocol Identification Number

NCT04229316

Brief Title

Safety And Efficacy Assessment of the zLock Facet Fusion System- A Pilot Study

Official Title

Safety And Efficacy Assessment of the zLock Facet Fusion System- A Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 12, 2018 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ZygoFix

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

stabilization, facet arthritis, spondylolisthesis, stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

zLock Facet Locking Implant System

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

zLOCK Facet Stabilization System

Intervention Description

zLOCK Facet Stabilization System is a device intended to provide posterior stability in lumbar spine in order to reduce lumbar back pains

Primary Outcome Measure Information:

Title

Safety assessment - no device related reoperation

Description

The safety of the zLOCK Facet Implant System will be established based on the absence of device related reoperations.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Efficacy assessment - achieving facet fusion 12 months post procedure

Description

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.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Claudication due to moderate to severe stenosis (central/ foraminal) as verified by imaging. 18< Age < 75 Weight < 100Kg Signed informed consent form At least 3 months of unsuccessful conventional treatments Exclusion Criteria: Fusion procedure performed or required in more than one inter-vertebrae space. Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation. Osteoporosis 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, kidney dialysis, or osteopenia, are relative contraindications. Obesity (BMI ≥30) Foreign body sensitivity Alcoholism, or drug abuse Subject with a cardiac pacemaker or other implanted electro medical device Subject with known condition of drug abuse and/or alcoholism 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hanna Levy, Dr

Organizational Affiliation

ZygoFix

Official's Role

Study Director

Facility Information:

Facility Name

Pecs University Hospital

City

Pecs

ZIP/Postal Code

H-7623

Country

Hungary

12. IPD Sharing Statement

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Safety And Efficacy Assessment of the zLock Facet Fusion System- A Pilot Study

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