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.

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Key information

Conditions

Low Back Pain Back Pain Bone Diseases Constriction, Pathologic Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases Spondylolisthesis Spondylolysis Spondylosis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pecs University Hospital

Pécs, H-7623, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

zLOCK Facet Stabilization System

Device

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

Primary outcomes

Safety assessment - no device related reoperation

Time frame: 3 months

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

Secondary outcomes

Efficacy assessment - achieving facet fusion 12 months post procedure

Time frame: 12 months

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.

Sponsors and collaborators

Lead sponsor

ZygoFix

Industry

Registry information

Important dates

Study start: 2018
Primary completion: 2024
Study completion: 2024
First posted: Jan 18, 2020
Registry last updated: Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed