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

NCT ID: NCT01493375

Last Updated: 2015-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prosthetic Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role collaborator

Aalborg University

OTHER

Sponsor Role collaborator

Northern Orthopaedic Division, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eileen Kohler, PhD student

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Surgery Research Unit, Aalborg University Hospital

Sten Rasmussen, M.D.

Role: STUDY_DIRECTOR

Northern Orthopaedic Division, Aalborg University Hospital

Locations

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Northern Orthopaedic Division, Clinic Frederikshavn

Frederikshavn, Northern Jutland, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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N-20100008

Identifier Type: -

Identifier Source: org_study_id

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