CompletedNot Applicable

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

Belgium, France82 participantsStarted 2020-11-20

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fusion of the cervical interbody cage used

Timeframe: 24 months

Trial details

NCT IDNCT04547959

SponsorMedicrea International

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-01

View on ClinicalTrials.gov More C-CURVE , Cervical Interbody Cage trials