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

NCT04229316 | Completed

• 1 other identifier: DMS-3343
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

stabilization, facet arthritis, spondylolisthesis, stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Efficacy assessment - achieving facet fusion 12 months post procedure

  12 months

Study Arms (1)

zLock Facet Locking Implant System

EXPERIMENTAL

Device: zLOCK Facet Stabilization System

Interventions

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

zLock Facet Locking Implant System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \< Age \< 75
• Weight \< 100Kg
• Signed informed consent form
• At least 3 months of unsuccessful conventional treatments

You may not qualify if:

• 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.

Sponsors & Collaborators

• ZygoFix: lead

Study Sites (1)

Pecs University Hospital

Pécs, H-7623, Hungary

Location

MeSH Terms

Conditions

Low Back Pain; Spondylolisthesis; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical

Study Officials

• Hanna Levy, Dr

  ZygoFix

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 18, 2020
• Study Start: April 12, 2018
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-02

Locations

HU (1)