Clinical Outcome After Anterior Cervical Decompression and Fusion and Cervical Total Disc Replacement

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Clinical Outcome After Anterior Cervical Decompression and Fusion and Cervical Total Disc Replacement

Conditions
-----------------
Cervical Disc Disorders

Intervention / Treatment
-----------------
* Procedure: Cervical Fusion
* Procedure: Cervical disc Prostheses


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cervical Fusion<br>patients with anterior cerivical decompression and fusion | Procedure: Cervical Fusion<br>* Cervical Fusion is performed with a titanium cage (Company Peter Brehm, Weisendorf, Germany) and a plating system (Company Aesculap, ABC plating system, Tuttlingen, Germany)<br>|
| Cervical Disc Prostheses<br>patients with cervical total disc replacement | Procedure: Cervical disc Prostheses<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain as assessed by VAS | Pain objectified by the VAS | Preoperative (baseline day 0), Follow up (24 months) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical fusion, cervical arthroplasty, cervicobrachial pain