Low Back PainNCT05266521
Safety and Efficacy Assessment of Using the zLOCK Facet Stabilization System
A study testing zLOCK Facet Stabilization System in people with Low Back Pain, run by ZygoFix at 2 sites in 2 countries.
Trial summary
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… 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
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Nov 2021to 30 Sep 2025
- 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:
- Degenerative Spondylolisthesis grade 1;
- Mild to Moderate stenosis;
- Degeneration of the facets.
- When used stand-alone disc height should be maximum 50% of the adjacent disc height.
- 18< Age <75
Show all 9Show fewer
- 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 motion segment.
- Acute or chronic spinal infections.
- Osteoporosis when used in adjunct to an anterior interbody cage (DEXA < -2.5).
- 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 or kidney dialysis.
- Obesity (BMI ≥30)
Show all 15Show fewer
- Unilateral application of device, except in combination with anterior interbody cages.
- Known sensitivity to Titanium.
- Alcoholism, or drug abuse
- Subject with a cardiac pacemaker or other implanted electro medical device
- 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.
- Tumor
- Fracture or other instabilities of the posterior elements.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Recruiting
MedizinischenFakultät der Universität Rostock
Rostock, 18055
Hanna Levy, Dr., +972522824966, hanna@qsitemed.com
Italy1 site, 1 recruiting
- Recruiting
AOU Policlinico "Paolo Giaccone"
Palermo
Fabio Torregrossa, M.D., giovanni.grasso@unipa.it
Giovanni Grasso, Prof.
About this study
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.
- 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 | 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 Receives: Device: zLOCK Facet Stabilization System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events as assessed by paucity of device related reoperation
The safety of the zLOCK Facet Implant System will be established based on the paucity of device-related reoperations.
Measured: 3 months
Secondary outcomes (1)
Change in pain level measured by Visual Analog Score for pain
The efficacy assessment of the ZygoFix Facet stabilization System will be established by change in pain level
.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start7 Nov 2021
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
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
- 80 participants (estimated)
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
- NCT05266521
- Sponsor's protocol ID
- DMS
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Assessment of Using the zLOCK Facet Stabilization System
- ClinicalTrials.gov ID
- NCT05266521
- Acronym / sponsor ID
- DMS
- Conditions
- Low Back Pain
- Keywords
- Stabilization, Facet arthritis, Spondylolisthesis, Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- ZygoFixIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2021 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 4 Mar 2022 (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.
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.
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 SystemDevice: 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient is scheduled for spine surgery with at least one of the following:
- When used stand-alone disc height should be maximum 50% of the adjacent disc height.
- 18< Age <75
- Weight < 100Kg
- Signed informed consent form
Key exclusion criteria (15 listed)
- Fusion procedure performed or required in more than one motion segment.
- Acute or chronic spinal infections.
- Osteoporosis when used in adjunct to an anterior interbody cage (DEXA < -2.5).
- 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 or kidney dialysis.
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
Incidence of Treatment-Emergent Adverse Events as assessed by paucity of device related reoperation
Time frame: 3 months
The safety of the zLOCK Facet Implant System will be established based on the paucity of device-related reoperations.
1 secondary outcome
Change in pain level measured by Visual Analog Score for pain
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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
2 sites in 2 countries: 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 2 sites in 2 countries.
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 9 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanna Levy, Dr. (+972522824966, hanna@qsitemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events as assessed by paucity of 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 7 Feb 2024.