Post-market Observational Clinical Study With the CE-marked Implantable Class IIb Medical Device "ITC CERVICAL"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Neck Disability Index (NDI)
研究概览
简要总结
The goal of this observational post-market study is to evaluate the clinical performance and safety of the ITC CERVICAL device, a CE-marked implantable cervical interbody fusion cage, in adult patients undergoing anterior cervical discectomy and fusion (ACDF) for symptomatic cervical degenerative disc disease.
The main questions it aims to answer are:
- Does the ITC CERVICAL device improve neck disability and pain after surgery?
- Does the device demonstrate adequate radiological performance in terms of cervical alignment, implant stability, and fusion-related outcomes?
- Is the device safe when used according to its intended purpose? Researchers will review retrospective clinical and radiological data from patients previously treated with the ITC CERVICAL device between 2020 and 2024. The outcomes assessed will include neck disability, pain intensity, neurological function, general health status, cervical lordosis, implant subsidence or migration, need for revision surgery, and the occurrence of adverse events.
Participants included in the study are adult patients who previously underwent two- or three-level ACDF surgery with implantation of the ITC CERVICAL device as part of routine clinical care. Clinical data collected before surgery, within 5 days after surgery, and at 3 months follow-up will be analyzed to assess the device's clinical benefits and safety profile.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant must be able to understand the nature, objectives, risks, and benefits of the study and provide free and informed consent, in accordance with current regulations.
- •Patients undergoing primary ACDF (Anterior Cervical Discectomy and Fusion) at two or three (contiguous) levels between C2 and C7
- •Diagnosis of symptomatic degenerative disc disease, including: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, spondylosis, osteophyte complexes, and foraminal stenosis
- •Availability and reliability of the neurological examination and pre- and post-operative clinical and radiological data and medical history
- •Adults (>18 years) treated between 2020 and 2024
排除标准
- •Patients undergoing primary ACDF on a single level between C2 and C7
- •History of previous surgeries in the anatomical area of interest
结局指标
主要结局
Neck Disability Index (NDI)
时间窗: From enrollment (which corresponds with the performance of the surgery) within 3 months of the surgery
The Neck Disability Index (NDI) is a patient-reported outcome measure assessing neck-related disability. The questionnaire consists of 10 items, each scored from 0 to 5, for a total score ranging from 0 to 50. Higher scores indicate greater disability and therefore a worse outcome. The study will evaluate the change in NDI score between baseline (time of surgery/enrollment) and 3 months after surgery.
次要结局
未报告次要终点