Improving Cervical Spine Alignment and Intervertebral Foramen Expansion Using a Novel Distally Expanding Cervical Facet Implant for Cervical Degenerative Disease

NCT07142174 — Not applicable, Recruiting, 20 participants, King Saud University

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Improving Cervical Spine Alignment and Intervertebral Foramen Expansion Using a Novel Distally Expanding Cervical Facet Implant (CeLFI) for Cervical Degenerative Disease

Registry	NCT07142174, acronym CeLFI
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	20 (Estimated)
Sponsor	King Saud University (Other)
Conditions	Cervical Degenerative Disease
Interventions	cervical facet implant will be introduced into the cervical levels that were mobile on flexion-extension x-ray and exhibited foramen stenosis or spondylolisthesis (Device)
Dates	start 2024-12-01, primary completion 2026-12-01 (estimated), completion 2027-06-01 (estimated), first posted 2025-08-26, last updated 2025-08-26
Locations	1 site in Saudi Arabia

-Summary

Cervical degenerative disease (CDD) resulting in myelopathy represents the commonest disease affecting the spinal cord in adults. Cervical radiculopathy can be associated with myelopathy or occurs alone. The treatment frequently requires surgical intervention; which could be done through anterior or posterior cervical spine approach, or a combination. In this study, we aim to evaluate the value of the innovative device (CeLFI; Cervical expanding facet implant), inserted from posterior approach, in widening the neural intervertebral foramina by providing an anterior distraction of the cervical facet joint space (FJS). Therefore, achieving indirect nerve decompression while maintaining cervical alignment and stability.

A prospective clinical study of a biomechanically and cadaver-validated device, following the pathway of similarly approved devices. Informed consent will be taken before the participation of every patient. 20 adult patients undergoing posterior surgery for CDD (for radiculopathy or myelopathy); from C2-6, will be included. Clinical evaluation will include pre- and post-operative standard outcome measures including visual analogue score (VAS), Neck disability index (NDI), and Modified Japanese Orthopedic Association score (mJOA). Standard radiologic evaluation will be performed before and after surgery including X-ray, computer tomography scan (CT), and Magnetic resonance imaging (MRI). Interim detailed safety analysis will be conducted after the first 5 cases are performed.

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+Arms and interventions

Arm	Type	Interventions	Description
Eligible Patients	Experimental	Device: cervical facet implant will be introduced into the cervical levels that were mobile on flexion-extension x-ray and exhibited foramen stenosis or spondylolisthesis	Patients who met the inclusion criteria and will go to intervention.

cervical facet implant will be introduced into the cervical levels that were mobile on flexion-extension x-ray and exhibited foramen stenosis or spondylolisthesis (Device): The patients will be managed according to the current practice for posterior cervical spine surgical approaches regarding patient positioning, surgical exposure, and neural decompression. The patients will be positioned prone with the head in a Mayfield headrest, All patients will be monitored using intraoperative motor evoked potentials (MEP) and somatosensory evoked potentials (SSEP). Intra-operative X-rays (antero-posterior and lateral) will be used to identify the index cervical level and to guide facet preparation and CeLFI insertion. Exposure of the posterior surface of the lateral mass at the index level of the cervical spine will be done either through a midline open technique or para-midline; inter-muscular approach (MIS). The facet joint-space (FJS) will be opened using a monopolar cautery with careful attention to preserve the joint's capsule on the lateral and medial boundaries. The FJS will be prepared using sequential dilators; designed for this purpose. Each dilator me

+Outcome measures

Primary outcomes

• Primary outcome (Radiological Evaluation): o Reduction of spondylolisthesis segment on X-rays (both intra-operative and post-operative within 1 week from surgery). This is defined here as a reduction of prior cervical vertebral mal-alignment to less t [1, 3, and 6 months after surgery]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
King Saud University Medical City	Riyadh	Saudi Arabia	Recruiting