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

This study has been completed.
Sponsor:
Collaborators:
Aarhus University Hospital
University of Aarhus
Aalborg University
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01493375
First received: December 14, 2011
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Prosthetic Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surgical Field Bacterial Contamination in Primary Hip and Knee Replacement Surgery

Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • Contamination of the operation area [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Description of the bacterial culture [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We want to describe the bacterial culture to achieve better knowledge of the bacterial combination.


Enrollment: 60
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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: Sten Rasmussen, M.D. Orthopaedic Surgery Research Unit, Aalborg University Hospital
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01493375     History of Changes
Other Study ID Numbers: N-20100008
Study First Received: December 14, 2011
Last Updated: May 1, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on May 19, 2013