Clinical Outcome After Anterior Cervical Decompression and Fusion and Cervical Total Disc Replacement
研究概览
详细说明
The study population consists of patients who are suffering from neck and cervicobrachial pain because of degenerative diseases of the cervical spine. In that population conservative treatment such as analgesia and physiotherapy is no more sufficient, so that surgery is necessary. For surgical treatment are chosen either total disc replacement with an cervical disc prostheses or anterior cervical decompression and fusion.
In the context of this work the clinical success of these surgical methods should be analasied by means of the neck disability index (NDI), the visual analogue scale (VAS) in centimeter, clinical examinations, the satisfaction of patients with the surgery and the occurrence of adverse events. The included patients are examined and seen before and after the surgery.
Furthermore the two different methods are compared to each other in order to detect a possible advantage of one type of surgery.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Bonn、德国、53127
- 招聘中
- University Hospital Bonn
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接触：
- Yorck Rommelspacher, Dr. med
- 邮箱：yorck.rommelspacher@ukb.uni-bonn.de
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NRW
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Bonn、NRW、德国、53127
- 招聘中
- Universitiy Hospital of Bonn
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接触：
- Charlotte Struwe
- 邮箱：struwe.charlotte@web.de
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- All patients who have to undergo surgery such as spondylodesis or disc prosthesis of the cervical spine because of degenerative diseases and who have been operated in the University Hospital of Bonn between 2011 and 2015.
Exclusion Criteria:
- Patients under the age of 18 years
- Pregnant women
- Patients who are not willing to participate in the study
- Patients unable to take part in the study because of any other known restriction or incompatibility
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Cervical Fusion
patients with anterior cerivical decompression and fusion
|
Cervical Fusion is performed with a titanium cage (Company Peter Brehm, Weisendorf, Germany) and a plating system (Company Aesculap, ABC plating system, Tuttlingen, Germany)
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Cervical Disc Prostheses
patients with cervical total disc replacement
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The total disc replacement is performed with eiter a Freedom® Cervical Disc, AxioMed Spine Corporation, Garfield Heights, Ohio, USA or Active® C, Company, Aesculap, Tuttlingen, Germany
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in pain as assessed by VAS
大体时间：Preoperative (baseline day 0), Follow up (24 months)
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Pain objectified by the VAS
|
Preoperative (baseline day 0), Follow up (24 months)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Neck disability Index
大体时间：Preoperative (baseline day 0), Follow up (24 months)
|
Restrictions in patients' daily life objecitfied by the NDI (neck disabiliy index)
|
Preoperative (baseline day 0), Follow up (24 months)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adverse events/ postoperative complications
大体时间：postoperative until Follow up in 24 months
|
Adverse events as for example reoperation because of adjacent segment degeneration or implant loosening
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postoperative until Follow up in 24 months
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Change in pharmacological pain management, WHO Scale
大体时间：Preoperative (baseline day 0), Follow up (24 months)
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Pain objectified by the analgesia scheme of the World Health Organisation
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Preoperative (baseline day 0), Follow up (24 months)
|
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Patient satisfaction with the surgical procedure
大体时间：Follow up (24 months)
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Satisfaction of patients with the result of the operation assessed by grades 1-6
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Follow up (24 months)
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合作者和调查者
调查人员
- 首席研究员：Yorck Rommelspacher, Dr. med、University Hospital, Bonn
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- UKBORTYC01
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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