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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \> 18

• Signed Informed Consent

• Patients undergoing posterior cervical Spine surgery for CDD (for radiculopathy or myelopathy)

Locations
Other Locations
Saudi Arabia
King Saud University Medical City
RECRUITING
Riyadh
Contact Information
Primary
Amro F Alhabib, Professor of Neurosurgery
amro.alhabib@gmail.com
00966506661582
Backup
Hani B Altaradi, Masters
Hanialtaradi@yahoo.com
00966554742599
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2027-06
Participants
Target number of participants: 20
Treatments
Experimental: Eligible Patients
Patients who met the inclusion criteria and will go to intervention.
Related Therapeutic Areas
Sponsors
Leads: King Saud University

This content was sourced from clinicaltrials.gov