Cervical Disc Disorders
Conditions
Keywords
cervical fusion, cervical arthroplasty, cervicobrachial pain
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.
Interventions
PROCEDURECervical 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)
PROCEDURECervical 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
Sponsors
University Hospital, Bonn
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain as assessed by VAS | Preoperative (baseline day 0), Follow up (24 months) | Pain objectified by the VAS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events/ postoperative complications | postoperative until Follow up in 24 months | Adverse events as for example reoperation because of adjacent segment degeneration or implant loosening |
| Change in pharmacological pain management, WHO Scale | Preoperative (baseline day 0), Follow up (24 months) | Pain objectified by the analgesia scheme of the World Health Organisation |
| Patient satisfaction with the surgical procedure | Follow up (24 months) | Satisfaction of patients with the result of the operation assessed by grades 1-6 |
Countries
Germany
Contacts
Primary ContactRobert Pflugmacher, PD Dr. med
Backup ContactYorck Rommelspacher, Dr. med
Outcome results
None listed