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Surgical Field Bacterial Contamination in Primary Total Hip (THA) and Knee (TKA) Arthroplasty

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ClinicalTrials.gov Identifier: NCT01493375
Recruitment Status : Suspended (Study principal investigator left the organization)
First Posted : December 16, 2011
Last Update Posted : May 28, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

In Denmark, approximately 13,000 operations are carried out every year. Prosthetic infection is a very serious condition and despite extensive prophylactic measures, prosthetic infections appear in 1-2 percent of the operated patients.

It is difficult to diagnose prosthetic infection with the techniques applied so far and incorrect diagnosis might imply unnecessary reoperations as well as unnoticed infections might lead to prolonged pain and invalidity.

The purpose of this study is to examine the value of these three techniques applied as a supplement to the existing technology and on this basis to prepare an algorithm for the examination of joint prosthesis infection.


Condition or disease
Prosthetic Infections

Study Design

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surgical Field Bacterial Contamination in Primary Hip and Knee Replacement Surgery
Study Start Date : June 2010
Primary Completion Date : December 2010
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Contamination of the operation area [ Time Frame: 12 months ]
    We want to examine the existence of contamination before an operation in hip and knee. Furthermore, we want to examine the contamination to achieve better knowledge of the bacterial combination.


Secondary Outcome Measures :
  1. Description of the bacterial culture [ Time Frame: 12 months ]
    We want to describe the bacterial culture to achieve better knowledge of the bacterial combination.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients from Northern Orthopaedic Division, Clinic Frederikshavn.
Criteria

Inclusion Criteria:

  • Patients who have been through an alloplastic operation in hip og knee.

Exclusion Criteria:

  • Patients with cancer or a bilateral disease
  • Former patients who have been through an operation with implants in hip or knee.
  • Patients who might be infected in the joint due to operation in hip or knee.
  • Lack of informed consent or inability to read/understand Danish
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493375


Locations
Denmark
Northern Orthopaedic Division, Clinic Frederikshavn
Frederikshavn, Northern Jutland, Denmark
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Aarhus University Hospital
University of Aarhus
Aalborg University
Investigators
Principal Investigator: Eileen Kohler, PhD student Orthopaedic Surgery Research Unit, Aalborg University Hospital
Study Director: Sten Rasmussen, M.D. Northern Orthopaedic Division, Aalborg University Hospital
More Information

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01493375     History of Changes
Other Study ID Numbers: N-20100008
First Posted: December 16, 2011    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Northern Orthopaedic Division, Denmark:
Contamination, hip operation, knee operation