Safety and Efficacy Assessment of Using the zLOCK Facet Stabilization System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-07

Study Completion Date

2025-09-30

Brief Summary

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The zLOCK Facet Stabilization System is a fixation device intended to provide posterior stability in the lumbar spine fusion procedure. The system can be placed either as an adjunct to an inter-vertebral anterior cage or as stand-alone with/ without additional decompression of the dural sac or nerve roots as appropriate for the specific patient and surgeon's discretion. The zLOCK implant is placed inside the facet to stabilize the motion and enhance the bony fusion of the joint. The zLOCK Facet Stabilization System is intended for single-level stabilization of a spinal motion segment in order to promote bony fusion of the joint. The zLOCK system is indicated for use from L1-L2 to L5-S1 joints.

The zLOCK implant is inserted into the facet joint space while adapting to the joint's changing geometry. Stabilization is achieved by a firm grip of each joint bone and resisting any relative motion. The zLOCK implant is placed percutaneously and requires only one incision per side, thereby reducing the invasiveness procedure duration and shortening the recovery period.

This pivotal study was designed in order to assess the safety and effectiveness of the zLOCK system.

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Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

zLOCK Facet Stabilization System

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patient is scheduled for spine surgery with at least one of the following:

* Degenerative Spondylolisthesis grade 1;
* Mild to Moderate stenosis;
* Degeneration of the facets.
2. When used stand-alone disc height should be maximum 50% of the adjacent disc height.
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 motion segment.
2. Acute or chronic spinal infections.
3. Osteoporosis when used in adjunct to an anterior interbody cage (DEXA \< -2.5).
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 or kidney dialysis.
6. Obesity (BMI ≥30)
7. Unilateral application of device, except in combination with anterior interbody cages.
8. Known sensitivity to Titanium.
9. Alcoholism, or drug abuse
10. Subject with a cardiac pacemaker or other implanted electro medical device
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.
14. Tumor
15. Fracture or other instabilities of the posterior elements.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No