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

U

University Hospital Bonn (UKB)

Status

Unknown

Conditions

Cervical Disc Disorders

Treatments

Procedure: Cervical disc Prostheses
Procedure: Cervical Fusion

Study type

Observational

Funder types

Other

Identifiers

NCT02498028
UKBORTYC01

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Cervical Fusion
Description:
patients with anterior cerivical decompression and fusion
Treatment:
Procedure: Cervical Fusion
Cervical Disc Prostheses
Description:
patients with cervical total disc replacement
Treatment:
Procedure: Cervical disc Prostheses

Trial contacts and locations

2

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Central trial contact

Robert Pflugmacher, PD Dr. med; Yorck Rommelspacher, Dr. med

Data sourced from clinicaltrials.gov

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