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

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Disc Disorders
• Intervention / Treatment: Procedure: Cervical Fusion; Procedure: Cervical disc Prostheses

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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Germany
  • Bonn, Germany, 53127
    • Recruiting
    • University Hospital Bonn
    • Contact: Yorck Rommelspacher, Dr. med; Email: yorck.rommelspacher@ukb.uni-bonn.de
  • NRW
    • Bonn, NRW, Germany, 53127
      • Recruiting
      • Universitiy Hospital of Bonn
      • Contact: Charlotte Struwe; Email: struwe.charlotte@web.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cervical Fusion; patients with anterior cerivical decompression and fusion	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; patients with cervical total disc replacement	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain as assessed by VAS	Pain objectified by the VAS	Preoperative (baseline day 0), Follow up (24 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
Patient satisfaction with the surgical procedure	Satisfaction of patients with the result of the operation assessed by grades 1-6	Follow up (24 months)

Collaborators and Investigators

• Sponsor: University Hospital, Bonn
• Investigators: Principal Investigator: Yorck Rommelspacher, Dr. med, University Hospital, Bonn

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): June 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: May 2, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 15, 2015

Study Record Updates

• Last Update Posted (Estimate): July 15, 2015
• Last Update Submitted That Met QC Criteria: July 14, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: cervical arthroplasty; cervical fusion; cervicobrachial pain
• Other Study ID Numbers: UKBORTYC01