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The number of patients requiring joint replacement is increasing due to its success in restoring function and pain relief, and the growing population of the elderly. One of the most serious complications of arthroplasty is joint prosthesis infection. Due to the absence of prospective, randomized, controlled studies, there is no consensus concerning diagnosis and treatment of prosthetic joint infections. The main objective of this trial is to evaluate the clinical efficacy of rifampin combination therapy versus monotherapy using cloxacillin or vancomycin in early staphylococcal infections after total hip and knee arthroplasty.
The study is a controlled randomized multicentre trial with 8 participating centres in Norway. We will include patients with the diagnosis of early infections (within 4 weeks post operatively)after hip or knee replacement. Patients with clinical signs of infection are scheduled for a standardized soft tissue revision. Diagnosis of staphylococci must be established by arthrocentesis or at surgical revision, and must grow in at least 2/8 cultures.The patients will randomly be assigned to antimicrobial therapy with or without rifampin by a randomization programme. Antibiotics will be given for 6 weeks. Two years follow-up. The study end points are final follow-up visit after two years or relapse of infection.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Buskerud Central Hospital
Drammen, Norway
Elverum Hospital
Elverum, Norway
Martina Hansen Hospital
Gjettum, Norway
Ringerike Hospital
Hønefoss, Norway
Lillehammer Hospital
Lillehammer, Norway
Oslo University Hospital, Ulleval
Oslo, Norway
Asker and Bærum Hospital
Rud, Norway
St.Olav Hospital
Trondheim, Norway
Start Date
April 1, 2006
Primary Completion Date
December 1, 2012
Completion Date
December 1, 2014
Last Updated
June 27, 2013
100
ESTIMATED participants
Rifampin-combination therapy
DRUG
Monotherapy
DRUG
Lead Sponsor
Oslo University Hospital
NCT06848387
NCT05899140
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02694458