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

Suspended

• Conditions: Prosthetic Infections

• Registration Number: NCT01493375
• Lead Sponsor: Northern Orthopaedic Division, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2010-12
• Study First Submitted: 2011-12-14
• Study First Submitted QC: 2011-12-14
• Study First Posted: 2011-12-16
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Contamination of the operation area	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

Name	Time	Method
Description of the bacterial culture	12 months	We want to describe the bacterial culture to achieve better knowledge of the bacterial combination.

Trial Locations

Locations (1)

Northern Orthopaedic Division, Clinic Frederikshavn; 🇩🇰 Frederikshavn, Northern Jutland, Denmark