Imaging of Fracture-related Infections (IFI)

• Conditions: infection; implant infection; osteomyelitis; trauma; fracture-related infections; infected osteosynthesisNL: infectie; fractuur-gerelateerde infecties, geïnfecteerd implantaat; geïnfecteerd osteosynthesemateriaal

• Registration Number: NL-OMON21936
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

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).

Exclusion Criteria

- 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. 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
The diagnostic accuracy (sensitivity, specificity, positive predictive value and negative predictive value) for WBC scintigraphy, FDG-PET/CT and MRI, in order to determine the most accurate imaging strategy for diagnosing fracture-related infections.

Secondary Outcome Measures

Name	Time	Method
- Determining whether the accuracy of the different image modalities is influenced by patient related factors such as in situ metal implants (plates, screws and intramedullary nails), recent surgery, open wounds or concomitant antibiotic treatment.<br /><br>- Determining which imaging modality provides the most valuable information to the surgeon for planning revision surgery such as the exact location of the infection, the extent of the infection or the presence of sequestra, cloacae, sinus tracts, intra-cortical or soft tissue abscesses.<br /><br>- To assess the quality of life and physical performance of patients with suspected fracture-related infections by using validated patient reported outcome measures. <br /><br>- To design an evidence-based, feasible and cost-effective diagnostic pathway for patients with suspected fracture-related infections.