Clinical trial NCT02498028: Clinical Outcome After Anterior Cervical Decompression and Fusion and Cervical Total Disc Replacement
Official title: Clinical Outcome After Anterior Cervical Decompression and Fusion and Cervical Total Disc Replacement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Disc Disorders
Keywords: cervical fusion
cervical arthroplasty
cervicobrachial pain
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Change in pain as assessed by VAS
timeFrame: Preoperative (baseline day 0), Follow up (24 months)
Secondary outcomes:
measure: Change in Neck disability Index
timeFrame: Preoperative (baseline day 0), Follow up (24 months)
Other outcomes:
measure: Adverse events/ postoperative complications
timeFrame: postoperative until Follow up in 24 months
measure: Change in pharmacological pain management, WHO Scale
timeFrame: Preoperative (baseline day 0), Follow up (24 months)
measure: Patient satisfaction with the surgical procedure
timeFrame: Follow up (24 months)
Locations:
city: Bonn
country: Germany
facility: Universitiy Hospital of Bonn
state: NRW
city: Bonn
country: Germany
facility: University hospital Bonn
Study officials:
affiliation: University Hospital, Bonn
name: Yorck Rommelspacher, Dr. med
role: PRINCIPAL_INVESTIGATOR
References: