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

Not Applicable

Recruiting

• Conditions: Cervical Degenerative Disease

• Registration Number: NCT07142174
• Lead Sponsor: King Saud University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-19
• Study First Submitted QC: 2025-08-19
• Last Update Submitted: 2025-08-19
• Study First Posted: 2025-08-26
• Last Update Posted: 2025-08-26
• Primary Completion: 2026-12
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
• 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

Trial Locations

Locations (1)

King Saud University Medical City; 🇸🇦 Riyadh, Saudi Arabia