Low Back PainNCT04229316
Safety And Efficacy Assessment of the zLock Facet Fusion System- A Pilot Study
A study testing zLOCK Facet Stabilization System in people with Low Back Pain, run by ZygoFix at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- zLOCK Facet Stabilization System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteHungary
- Study dates
- 12 Apr 2018to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Low Back Pain
- Being tested
- zLOCK Facet Stabilization System
- Keywords
- stabilization, facet arthritis, spondylolisthesis, stenosis
- Medical subject headings
- Low Back Pain, Spondylolisthesis, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zLOCK Facet Stabilization SystemDevice
zLOCK Facet Stabilization System is a device intended to provide posterior stability in lumbar spine in order to reduce lumbar back pains
| Study group | Role | What they receive |
|---|---|---|
| zLock Facet Locking Implant System | Experimental | Not described Receives: Device: zLOCK Facet Stabilization System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start12 Apr 2018
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZygoFix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hanna Levy, Dr, Study director, ZygoFix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229316
- Sponsor's protocol ID
- DMS-3343
- Status last verified
- Feb 2024
- First submitted
- 8 Jan 2020
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety And Efficacy Assessment of the zLock Facet Fusion System- A Pilot Study
- ClinicalTrials.gov ID
- NCT04229316
- Acronym / sponsor ID
- DMS-3343
- Conditions
- Low Back Pain
- Keywords
- stabilization, facet arthritis, spondylolisthesis, stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ZygoFixIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| zLock Facet Locking Implant System | Experimental | Device: zLOCK Facet Stabilization System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patient is scheduled for spine surgery with at least one of the following:
- Claudication due to moderate to severe stenosis (central/ foraminal) as verified by imaging.
- 18< Age < 75
- Weight < 100Kg
- Signed informed consent form
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zLOCK Facet Stabilization SystemzLOCK Facet Stabilization System is a device intended to provide posterior stability in lumbar spine in order to reduce lumbar back pains | Device | zLock Facet Locking Implant System |
Primary outcome
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.
1 secondary outcome
Efficacy assessment - achieving facet fusion 12 months post procedure
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanna Levy, Dr study director
ZygoFix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zLOCK Facet Stabilization System in people with Low Back Pain, run by ZygoFix at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment - no device related reoperation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.