Assessment of the zLOCK Facet Stabilization System for Low Back Pain

Safety and Efficacy Assessment of Using the zLOCK Facet Stabilization System

This study is testing a new device to see if it can help people with low back pain by stabilizing their spine during surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: ZygoFix (Industry-sponsored)
• Locations: 2 sites (Rostock and 1 other locations)
• Trial ID: NCT05266521 on ClinicalTrials.gov

What this trial studies

The zLOCK Facet Stabilization System is designed to provide posterior stability during lumbar spine fusion procedures. This device can be used either as an adjunct to an inter-vertebral anterior cage or as a stand-alone solution, depending on the patient's needs and the surgeon's discretion. It is inserted into the facet joint space to stabilize motion and promote bony fusion, with a focus on single-level stabilization from L1-L2 to L5-S1. The procedure is minimally invasive, requiring only one incision per side.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with degenerative spondylolisthesis, mild to moderate stenosis, or facet degeneration who have not responded to conventional treatments.

Not a fit: Patients with multiple motion segment fusions, acute or chronic spinal infections, or conditions that preclude fusion will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve outcomes for patients suffering from low back pain due to facet joint issues.

How similar studies have performed: While the zLOCK system represents a novel approach, similar stabilization techniques have shown promise in previous studies.

Eligibility criteria

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.

Where this trial is running

Rostock and 1 other locations

• MedizinischenFakultät der Universität Rostock — Rostock, Germany (Recruiting)
• AOU Policlinico "Paolo Giaccone" — Palermo, Italy (Recruiting)

Study contacts

• Study coordinator: Hanna Levy, Dr.

Conditions Low Back Pain; Stabilization; Facet arthritis; Spondylolisthesis; Stenosis