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

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 1, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

June 30, 2027

Conditions
Cervical Degenerative Disease
Interventions
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

"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"

Trial Locations (1)

Unknown

RECRUITING

King Saud University Medical City, Riyadh

All Listed Sponsors
lead

King Saud University

OTHER