Status:
UNKNOWN
Diagnosis and Bacterial Identification of Periprosthetic Joint Infection With Microbial-ID
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Zimmer Biomet
Conditions:
Periprosthetic Joint Infection
PJI
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this study is to demonstrate the validity of the Microbial- ID test to aid in diagnosis of periprosthetic joint infection (PJI) in terms of sensitivity and specificity.
Detailed Description
In the diagnosis of periprosthetic joint infection (PJI) there is no golden standard test. Multiple definitions for the diagnosis of PJI exist, such as the European Bone and Joint Infection Society (E...
Eligibility Criteria
Inclusion
- Patient has complaints (pain, stiffness) about the prosthetic joint And has clinical features for joint infection at physical examination (swelling, redness, warm, sinus tract) AND has an elevated serum CRP (\>10 mg/L)
- Patient is scheduled for a puncture AND/OR surgery, with harvesting of synovial fluid
- Patient ≥ 18 years of age
- Patient is competent, able, and willing to provide written informed consent
Exclusion
- Treatment with antibiotics ≤2 weeks prior to puncture and/or surgery;
- Other obvious reason(s) for implant dysfunction, such as: fracture, an implant breakage, a malposition, and/or a tumour.
Key Trial Info
Start Date :
April 25 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05320354
Start Date
April 25 2022
End Date
December 1 2025
Last Update
February 23 2023
Active Locations (6)
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1
Charité Universitätsmedizin Berlin
Berlin, Germany
2
UMC Utrecht
Utrecht, Netherlands, 3584CX
3
Hospitalar do Porto,
Porto, Portugal
4
Valdoltra Orthopeadic Hospital,
Valdoltra, Slovenia