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

Not Applicable

Completed

• Conditions: C-CURVE , Cervical Interbody Cage; Cervical Disc Disease; Cervical Discopathy
• Interventions: Device: cervical interbody cage C-CURVE

• Registration Number: NCT04547959
• Lead Sponsor: Medicrea International

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-07
• Study First Posted: 2020-09-14
• Study Start: 2020-11-20
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C-CURVE Titane	cervical interbody cage C-CURVE	According the routine practice of the investigator surgeon, the interbody cage C-CURVE in Titane is used

Primary Outcome Measures

Name	Time	Method
Fusion of the cervical interbody cage used	24 months	Measures the bone fusion thanks to the CTscan

Secondary Outcome Measures

Name	Time	Method
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)
Fusion of the cervical interbody cage used	6 and 12 months postoperative	Measures the bone fusion thanks to the CTscan
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)
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

Trial Locations

Locations (10)

Clinique Belharra; 🇫🇷 Bayonne, France

Clinique du Parc; 🇫🇷 Castelnau-le-Lez, France

CH WAPI; 🇧🇪 Tournai, Belgium

Groupe Hospitalier La Rochelle-Re-Aunis; 🇫🇷 La Rochelle, France

Clinique Clairval; 🇫🇷 Marseille, France

Clinique de l'Union; 🇫🇷 Saint-Jean, France

CHRU Bretonneau; 🇫🇷 Tours, France

Centre Orthopédique Santy; 🇫🇷 Lyon, France

Clinique Charcot; 🇫🇷 Sainte-Foy-lès-Lyon, France

Centre de consultations spécialisées de la Sauvegarde; 🇫🇷 Lyon, France