Prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE (Titanium) Manufactured by MEDICREA®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 11
- 主要终点
- Fusion of the cervical interbody cage used
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Fusion of the cervical interbody cage used
时间窗: 24 months
Measures the bone fusion thanks to the CTscan
次要结局
- Quality of life with modified SF-12(Preoperative, and 6, 12 and 24 months postoperative)
- Satisfaction patient(6, 12 and 24 months)
- Fusion of the cervical interbody cage used(6 and 12 months postoperative)
- NDI(Neck Disability Index)(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(Preoperative, and 6, 12 and 24 months postoperative)
- Complications(peroperative and 6, 12 and 24 months postoperative)
- VAS (Pain)(Preoperative, and 6, 12 and 24 months postoperative)