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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Device: cervical interbody cage C-CURVE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, multicenter, non-comparative and interventional post market clinical follow-up
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C-CURVE Titane<br>According the routine practice of the investigator surgeon, the interbody cage C-CURVE in Titane is used | Device: cervical interbody cage C-CURVE<br>* ACDF: Anterior Cervical Discectomy and Fusion with a C-CURVE cage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion of the cervical interbody cage used | Measures the bone fusion thanks to the CTscan | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion of the cervical interbody cage used | Measures the bone fusion thanks to the Xrays | 6, 12 and 24 months | 
| Quality of life with modified SF-12 | Score of the modified SF-12 (to 0 (better) to 100 (worst) | Preoperative, and 6, 12 and 24 months postoperative | 
| Satisfaction patient | Score of the PSI (scale: 1/2/3/4 ; 1: Better) | 6, 12 and 24 months | 
| VAS (Pain) | Score of the pain (to 0 (better) to 10 (worst) | Preoperative, and 6, 12 and 24 months postoperative | 
| NDI(Neck Disability Index) | Score of the pain (to 0 (better) to 50 (worst) | Preoperative, and 6, 12 and 24 months postoperative | 
| Cervical spinal radiographic parameters (Cobb angle, C2C7 angle, Segmental lordosis/kyphosis, disk height, subsidence, alignment restauration ) for C-CURVE Titanium only | radiographic measurements | Preoperative, and 6, 12 and 24 months postoperative | 
| Complications | All Adverse Events related to the study device, instruments and/or the study procedure and all SAEs must be reported | peroperative and 6, 12 and 24 months postoperative | 
| Fusion of the cervical interbody cage used | Measures the bone fusion thanks to the CTscan | 6 and 12 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical disc disease, cervical disc degeneration, C-CURVE , cervical interbody cage