Clinical Outcome After Anterior Cervical Decompression and Fusion and Cervical Total Disc Replacement
1 other identifier
observational
80
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2011
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 15, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedJuly 15, 2015
July 1, 2015
4.4 years
May 2, 2015
July 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in pain as assessed by VAS
Pain objectified by the VAS
Preoperative (baseline day 0), Follow up (24 months)
Secondary Outcomes (1)
Change in Neck disability Index
Preoperative (baseline day 0), Follow up (24 months)
Other Outcomes (3)
Adverse events/ postoperative complications
postoperative until Follow up in 24 months
Change in pharmacological pain management, WHO Scale
Preoperative (baseline day 0), Follow up (24 months)
Patient satisfaction with the surgical procedure
Follow up (24 months)
Study Arms (2)
Cervical Fusion
patients with anterior cerivical decompression and fusion
Cervical Disc Prostheses
patients with cervical total disc replacement
Interventions
Cervical Fusion is performed with a titanium cage (Company Peter Brehm, Weisendorf, Germany) and a plating system (Company Aesculap, ABC plating system, Tuttlingen, Germany)
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
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Universitiy Hospital of Bonn
Bonn, North Rhine-Westphalia, 53127, Germany
University hospital Bonn
Bonn, 53127, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yorck Rommelspacher, Dr. med
University Hospital, Bonn
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med. Yorck Rommelspacher
Study Record Dates
First Submitted
May 2, 2015
First Posted
July 15, 2015
Study Start
January 1, 2011
Primary Completion
June 1, 2015
Study Completion
August 1, 2015
Last Updated
July 15, 2015
Record last verified: 2015-07