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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
ACDF: Anterior Cervical Discectomy and Fusion with a C-CURVE cage
CH WAPI
Tournai, Belgium
Clinique Belharra
Bayonne, France
Clinique du Parc
Castelnau-le-Lez, France
Groupe Hospitalier La Rochelle-Re-Aunis
La Rochelle, France
Centre de consultations spécialisées de la Sauvegarde
Lyon, France
Centre Orthopédique Santy
Lyon, France
Clinique Clairval
Marseille, France
Clinique de l'Union
Saint-Jean, France
Clinique Charcot
Sainte-Foy-lès-Lyon, France
CHRU Bretonneau
Tours, France
Fusion of the cervical interbody cage used
Measures the bone fusion thanks to the CTscan
Time frame: 24 months
Fusion of the cervical interbody cage used
Measures the bone fusion thanks to the Xrays
Time frame: 6, 12 and 24 months
Quality of life with modified SF-12
Score of the modified SF-12 (to 0 (better) to 100 (worst)
Time frame: Preoperative, and 6, 12 and 24 months postoperative
Satisfaction patient
Score of the PSI (scale: 1/2/3/4 ; 1: Better)
Time frame: 6, 12 and 24 months
VAS (Pain)
Score of the pain (to 0 (better) to 10 (worst)
Time frame: Preoperative, and 6, 12 and 24 months postoperative
NDI(Neck Disability Index)
Score of the pain (to 0 (better) to 50 (worst)
Time frame: 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
Time frame: 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
Time frame: peroperative and 6, 12 and 24 months postoperative
Fusion of the cervical interbody cage used
Measures the bone fusion thanks to the CTscan
Time frame: 6 and 12 months postoperative
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