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

• Conditions: Cervical Disc Disorders
• Interventions: Procedure: Cervical Fusion; Procedure: Cervical disc Prostheses

• Registration Number: NCT02498028
• Lead Sponsor: University Hospital, Bonn

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2015-05-02
• Primary Completion: 2015-06
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-14
• Last Update Submitted: 2015-07-14
• Study First Posted: 2015-07-15
• Last Update Posted: 2015-07-15
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cervical Fusion	Cervical Fusion	patients with anterior cerivical decompression and fusion
Cervical Disc Prostheses	Cervical disc Prostheses	patients with cervical total disc replacement

Primary Outcome Measures

Name	Time	Method
Change in pain as assessed by VAS	Preoperative (baseline day 0), Follow up (24 months)	Pain objectified by the VAS

Secondary Outcome Measures

Name	Time	Method
Change in Neck disability Index	Preoperative (baseline day 0), Follow up (24 months)	Restrictions in patients' daily life objecitfied by the NDI (neck disabiliy index)

Trial Locations

Locations (2)

Universitiy Hospital of Bonn; 🇩🇪 Bonn, NRW, Germany

University hospital Bonn; 🇩🇪 Bonn, Germany