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

• Sponsor: ZygoFix (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04229316
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 73.7
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Device: zLOCK Facet Stabilization System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety And Efficacy Assessment of the zLock Facet Fusion System- A Pilot Study
• Actual Study Start Date: Apr 12, 2018
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Safety assessment - no device related reoperation [3 months]

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

Secondary Outcome Measures

1. Efficacy assessment - achieving facet fusion 12 months post procedure [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. Claudication due to moderate to severe stenosis (central/ foraminal) as verified by imaging.

2. 18< Age < 75

3. Weight < 100Kg

4. Signed informed consent form

5. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pecs University Hospital	Pecs		Hungary	H-7623

Sponsors and Collaborators

• ZygoFix

Investigators

• Study Director: Hanna Levy, Dr, ZygoFix

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ZygoFix
• ClinicalTrials.gov Identifier: NCT04229316
• Other Study ID Numbers: DMS-3343
• First Posted: Jan 18, 2020
• Last Update Posted: Jul 14, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ZygoFix: stabilization, facet arthritis, spondylolisthesis, stenosis
• Additional relevant MeSH terms: Low Back Pain

Study Results

No Results Posted as of Jul 14, 2022