C-CURVE , Cervical Interbody Cage, Cervical Disc Disease, Cervical Discopathy
Conditions
Keywords
cervical disc disease, cervical disc degeneration, C-CURVE , cervical interbody cage
Brief 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.
Interventions
DEVICEcervical interbody cage C-CURVE
ACDF: Anterior Cervical Discectomy and Fusion with a C-CURVE cage
Sponsors
Medicrea International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multicenter, non-comparative and interventional post market clinical follow-up
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fusion of the cervical interbody cage used | 24 months | Measures the bone fusion thanks to the CTscan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fusion of the cervical interbody cage used | 6, 12 and 24 months | Measures the bone fusion thanks to the Xrays |
| Quality of life with modified SF-12 | Preoperative, and 6, 12 and 24 months postoperative | Score of the modified SF-12 (to 0 (better) to 100 (worst) |
| Satisfaction patient | 6, 12 and 24 months | Score of the PSI (scale: 1/2/3/4 ; 1: Better) |
| Complications | peroperative and 6, 12 and 24 months postoperative | All Adverse Events related to the study device, instruments and/or the study procedure and all SAEs must be reported |
| NDI(Neck Disability Index) | Preoperative, and 6, 12 and 24 months postoperative | Score of the pain (to 0 (better) to 50 (worst) |
| Cervical spinal radiographic parameters (Cobb angle, C2C7 angle, Segmental lordosis/kyphosis, disk height, subsidence, alignment restauration ) for C-CURVE Titanium only | Preoperative, and 6, 12 and 24 months postoperative | radiographic measurements |
| VAS (Pain) | Preoperative, and 6, 12 and 24 months postoperative | Score of the pain (to 0 (better) to 10 (worst) |
Countries
Belgium, France
Outcome results
None listed