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

Cervical Disc Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02498028
• Other study ID #: UKBORTYC01
• Status: Recruiting
• Phase: N/A
• First received: May 2, 2015
• Last updated: July 14, 2015
• Start date: January 2011
• Est. completion date: August 2015

Study information

• Verified date: July 2015
• Source: University Hospital, Bonn
• Contact: Robert Pflugmacher, PD Dr. med
• Email: robert.pflugmacher[@]ukb.uni-bonn.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical Disc Disorders

Intervention

Procedure:
• 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)
• 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

Locations

Country	Name	City	State
Germany	Universitiy Hospital of Bonn	Bonn	NRW
Germany	University hospital Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Change in pharmacological pain management, WHO Scale	Pain objectified by the analgesia scheme of the World Health Organisation	Preoperative (baseline day 0), Follow up (24 months)	No
Other	Patient satisfaction with the surgical procedure	Satisfaction of patients with the result of the operation assessed by grades 1-6	Follow up (24 months)	No
Primary	Change in pain as assessed by VAS	Pain objectified by the VAS	Preoperative (baseline day 0), Follow up (24 months)	No
Secondary	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)	No