Accuracy of diagnostic imaging techniques in patients with a suspected fracture-related infectio
- Conditions
- fracture-related infectionimplant infection100040181000594210017322
- Registration Number
- NL-OMON46568
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Patients >= 18 years with a suspected fracture-related infection will be included after a signed informed consent. The clinical suspicion of a fracture-related infection is based on several (clinical) parameters as defined by the consensus group of the international Arbeitsgemeinschaft für Osteosynthesefragen (AO Foundation) (1). See protocol, number 4.2, page 13.
- Patients < 18 years, pregnant or lactating women, patients with claustrophobia or known allergies for intravenous contrast agents will be excluded from this study.
- Patients with evident acute postoperative surgical site infections and who don*t need additional diagnostic imaging because the clinical diagnosis of infection could be made without any doubt on the physical examination (e.g. evident pus drainage from the wound or wound dehiscence with exposed implants) will be excluded from this study (1, 9). According to the current practice, these patients don*t need additional imaging, because a reoperation will be performed anyway.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The diagnostic accuracy of all different imaging modalities for diagnosing<br /><br>fracture-related infections (sensitivity, specificity, positive predictive<br /><br>value and negative predictive value).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters:<br /><br>- Scores of the EQ5D and SMFA questionnaires in order to assess the quality of<br /><br>life and physical performance of patients with fracture-related infections.<br /><br>- Scores of the iMCQ and iPCQ questionnaires in order to assess the medical<br /><br>costs associated with fracture-related infections.</p><br>