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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cervical Disc Disorders

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cervical Fusion

patients with anterior cerivical decompression and fusion

Cervical Fusion

Intervention Type 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)

Cervical Disc Prostheses

patients with cervical total disc replacement

Cervical disc Prostheses

Intervention Type 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

Interventions

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Cervical 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)

Intervention Type PROCEDURE

Cervical disc Prostheses

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No