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

NCT ID: NCT07142174

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2027-06-30

Brief 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.

Conditions

Cervical Degenerative Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eligible Patients

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

Group Type: EXPERIMENTAL

cervical facet implant will be introduced into the cervical levels that were mobile on flexion-extension x-ray and exhibited foramen stenosis or spondylolisthesis

Intervention Type: 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

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

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

Amro Fayez Alhabib

Professor of Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

King Saud University Medical City

Riyadh, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Amro F Alhabib, Professor of Neurosurgery

Role: CONTACT

amro.alhabib@gmail.com

00966506661582

Hani B Altaradi, Masters

Role: CONTACT

Hanialtaradi@yahoo.com

00966554742599

Facility Contacts

Hani B Altaradi, Masters

Role: primary

Hanialtaradi@yahoo.com

00966554742599

Other Identifiers

2329

Identifier Type: OTHER

Identifier Source: secondary_id

E-21-6224

Identifier Type: -

Identifier Source: org_study_id