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

Medicrea

Status

Completed

Conditions

C-CURVE , Cervical Interbody Cage

Cervical Disc Disease

Cervical Discopathy

Treatments

Device: cervical interbody cage C-CURVE

Study type

Interventional

Funder types

Industry

Identifiers

NCT04547959

MDT220112102

Details and patient eligibility

About

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.

Enrollment

82 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient operated with C-CURVE TITANIUM (MEDICREA) for one or several levels (3 maximum)
Cage implanted with the bone graft "OSMOSYS" (MEDICREA) or an auto bone graft from patients
Patient ≥ 18 years
Patient affiliated to health care insurance (social security in France)
Patient who signed an informed consent form
Patient able and willing to complete a self-administered questionnaire
Patient able to understand protocol and the planning visit and willing to perform all of them
Patient with a pathology indicated in the instruction for use of the implant

Exclusion criteria

Patient with no preoperative data available (X-rays, questionnaires)
Hybrid installation or cervical additional fixation
Patient contraindicated for X-ray(s) and/or CT-Scan(s)
Patient with contraindications indicated in the instruction for use of the implant
Patient judged as non-compliant by the investigator, not unable to come back for the follow-up visits (for example: patient living more than 100 km away).
Patient who declined to participate to the study or unable to give his consent Vulnerable population as explained in the protocol