Distally expanding cervical facet implant to improve neck alignment and widen nerve openings

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.