NCT04547959

Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE ( Titanium) Manufactured by MEDICREA®

Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE (Titanium) Manufactured by MEDICREA®

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Medicrea International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study includes one type of product named C-CURVE which is a Stand-alone Cervical Interbody Cage. This product is available in two materials: PEEK and Titanium. The C-Curve Cervical Interbody Devices is one single implant used for insertion between two adjacent vertebrae (cervical spine). C-Curve has been designed to restore and/or maintain adequate interbody height, and thus help stabilize one or more cervical levels while fusion occurs. This system has also as objectives to increase of the quality of life, decrease patient's pain and decrease a potential dysphagia (clinical performances). This system must only be used in the cervical spine. This post-market clinical follow-up (PMCF) study aims to confirm the acceptable benefits/risk profile of the device for the patients and to fill essential requirements to maintain the CE mark through a clinical evaluation.

Conditions

• C-CURVE , Cervical Interbody Cage
• Cervical Disc Disease
• Cervical Discopathy

Interventions

Type	Name	Description
DEVICE	cervical interbody cage C-CURVE	ACDF: Anterior Cervical Discectomy and Fusion with a C-CURVE cage

Timeline

• Start date: 2020-11-20
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2020-09-14
• Last updated: 2025-01-13

Locations

10 sites across 2 countries: Belgium, France