Prospective Follow-up Study of the Aesculap Quintex® Anterior Cervical Plating System After a Minimum of One Year
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical Results measured by Neck Disability Index (NDI)
研究概览
简要总结
Prospective study, not randomised, non-interventional, monocentric, investigating an intended patient cohort of 60 patients already operated on the cervical spine due to degenerative disc disease of the cervical spine down to the first thoracolumbar VBR (C2-T1), who received a Quintex plate for stabilisation
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients who received a Quintex® Anterior Cervical Plate since 2014 until approx. end 2018 (minimum Follow-up is one year) in the study center
排除标准
- •Patient informed consent not signed
- •Patients living outside a radius of 80 km around the study center
结局指标
主要结局
Clinical Results measured by Neck Disability Index (NDI)
时间窗: One retrospective visit, between one and approx. five years post-op.
The NDI is designed to measure neck-specific disability. The questionnaire has 10 items to measure patient-reported disability secondary to neck pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation and patients rate their status from 0 (best) to 5 (worst imaginable). Individual item responses are summed to a total score, where 0 points indicate no activity limitations and 50 points indicate complete activity limitation.
次要结局
- Patient satisfaction(One retrospective visit, between one and approx. five years post-op.)
- Neck and arm pain(One retrospective visit, between one and approx. five years post-op.)
- Quality of life measured by EQ-5D-5L(One retrospective visit, between one and approx. five years post-op.)
- Dysphagia assessment(One retrospective visit, between one and approx. five years post-op.)
- Complications(One retrospective visit, between one and approx. five years post-op.)
- Postoperative Need for Pain medication(One retrospective visit, between one and approx. five years post-op.)
- Radiological outcome from standard x-rays(One retrospective visit, between one and approx. five years post-op.)