Clinical Outcome After Anterior Cervical Decompression and Fusion and Cervical Total Disc Replacement
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
-
Bonn、ドイツ、53127
- 募集
- University Hospital Bonn
-
コンタクト：
- Yorck Rommelspacher, Dr. med
- メール：yorck.rommelspacher@ukb.uni-bonn.de
-
-
NRW
-
Bonn、NRW、ドイツ、53127
- 募集
- Universitiy Hospital of Bonn
-
コンタクト：
- Charlotte Struwe
- メール：struwe.charlotte@web.de
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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)
|
|
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in pain as assessed by VAS
時間枠：Preoperative (baseline day 0), Follow up (24 months)
|
Pain objectified by the VAS
|
Preoperative (baseline day 0), Follow up (24 months)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Neck disability Index
時間枠：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)
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adverse events/ postoperative complications
時間枠：postoperative until Follow up in 24 months
|
Adverse events as for example reoperation because of adjacent segment degeneration or implant loosening
|
postoperative until Follow up in 24 months
|
|
Change in pharmacological pain management, WHO Scale
時間枠：Preoperative (baseline day 0), Follow up (24 months)
|
Pain objectified by the analgesia scheme of the World Health Organisation
|
Preoperative (baseline day 0), Follow up (24 months)
|
|
Patient satisfaction with the surgical procedure
時間枠：Follow up (24 months)
|
Satisfaction of patients with the result of the operation assessed by grades 1-6
|
Follow up (24 months)
|
協力者と研究者
捜査官
- 主任研究者：Yorck Rommelspacher, Dr. med、University Hospital, Bonn
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- UKBORTYC01
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