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The aim of this study is to examine the clinical outcome after anterior cervical decompression and fusion, and cervical disc prostheses in general. Additionally these two surgical methods for degenerative diseases of the cercival spine are analyzed comparatively in order to see whether one procedure should be preferred.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical Fusion | patients with anterior cerivical decompression and fusion |
| |
| Cervical Disc Prostheses | patients with cervical total disc replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical Fusion | Procedure | Cervical Fusion is performed with a titanium cage (Company Peter Brehm, Weisendorf, Germany) and a plating system (Company Aesculap, ABC plating system, Tuttlingen, Germany) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain as assessed by VAS | Pain objectified by the VAS | Preoperative (baseline day 0), Follow up (24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neck disability Index | Restrictions in patients' daily life objecitfied by the NDI (neck disabiliy index) | Preoperative (baseline day 0), Follow up (24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events/ postoperative complications | 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 |
Inclusion Criteria:
Exclusion Criteria:
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Patients of the University Hospital of Bonn who are suffering from neck and cervicobrachial pain that cannot be treated anymore by conservative methods and have to undergo surgery such as cervical fusion or cevical disc arthroplasty.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Pflugmacher, PD Dr. med | Contact | robert.pflugmacher@ukb.uni-bonn.de | ||
| Yorck Rommelspacher, Dr. med | Contact | Yorck.Rommelspacher@ukb.uni-bonn.de |
| Name | Affiliation | Role |
|---|---|---|
| Yorck Rommelspacher, Dr. med | University Hospital, Bonn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitiy Hospital of Bonn | Recruiting | Bonn | North Rhine-Westphalia | 53127 | Germany |
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| ID | Term |
|---|---|
| D007714 | Klippel-Feil Syndrome |
| ID | Term |
|---|---|
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Cervical disc Prostheses | Procedure | 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 |
|
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 | Satisfaction of patients with the result of the operation assessed by grades 1-6 | Follow up (24 months) |
| University hospital Bonn | Recruiting | Bonn | 53127 | Germany |
|
| D009139 |
| Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |