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

King Saud University

Status: Enrolling

Conditions: Cervical Degenerative Disease

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT07142174

E-21-6224

2329

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Eligible Patients

Experimental group

Description:

Patients who met the inclusion criteria and will go to intervention.

Treatment:

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