Distally expanding cervical facet implant to improve neck alignment and widen nerve openings
Improving Cervical Spine Alignment and Intervertebral Foramen Expansion Using a Novel Distally Expanding Cervical Facet Implant (CeLFI) for Cervical Degenerative Disease
This study tests a new distally expanding cervical facet implant to widen nerve openings and maintain alignment in adults having posterior surgery for cervical degenerative disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King Saud University Academic / other |
| Locations | 1 site (Riyadh) |
| Trial ID | NCT07142174 on ClinicalTrials.gov |
What this trial studies
This prospective clinical study will insert a novel distally expanding cervical facet implant (CeLFI) via a posterior approach to provide anterior distraction of the facet joint space and thereby enlarge the intervertebral foramina. The device has prior biomechanical and cadaver validation and will be placed at levels that are mobile on flexion-extension x-rays and show foraminal stenosis or spondylolisthesis. Twenty adult patients undergoing posterior cervical surgery for radiculopathy or myelopathy will be enrolled with informed consent and followed with clinical exams and imaging to document alignment, foraminal size, neurologic status, and device-related safety. Outcomes will compare pre- and postoperative radiographs and clinical measures to determine whether the implant achieves indirect nerve decompression while preserving stability.
Who should consider this trial
Good fit: Adults over 18 undergoing posterior cervical spine surgery for degenerative radiculopathy or myelopathy with mobile levels showing foraminal stenosis or spondylolisthesis are ideal candidates.
Not a fit: Patients with non-degenerative cervical conditions (infection, tumor, trauma), severe instability, or those not receiving a posterior approach are unlikely to benefit from this device.
Why it matters
Potential benefit: If successful, the implant could relieve nerve compression while preserving cervical alignment and stability, potentially avoiding more invasive anterior procedures.
How similar studies have performed: Similar posterior facet spacer approaches have shown biomechanical and early clinical promise, but this specific distally expanding CeLFI device is novel and is being tested in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 * Signed Informed Consent * Patients undergoing posterior cervical Spine surgery for CDD (for radiculopathy or myelopathy) Exclusion Criteria: * Non-degenerative cervical spine pathologies, including infection, tumor, or trauma.
Where this trial is running
Riyadh
- King Saud University Medical City — Riyadh, Saudi Arabia (Recruiting)
Study contacts
- Study coordinator: Amro F Alhabib, Professor of Neurosurgery
- Email: amro.alhabib@gmail.com
- Phone: 00966506661582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.