Status:
COMPLETED
Identification of Infections in Hip Arthroplasty Loosening.
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Loosening, Prosthesis
Eligibility:
All Genders
18+ years
Brief Summary
Recent data showed that the rate of periprosthetic infections in patients undergoing a hip arthroplasty revision for aseptic loosening is higher than what can be ascertained with conventional methods....
Detailed Description
Periprosthetic infection following hip arthroplasty is one of the main causes of implant failure that leads to multiple surgical interventions, prolonged hospitalization, and higher complication rate ...
Eligibility Criteria
Inclusion
- Hip arthroplasty revision for aseptic loosening, diagnosis determined as probable according to the following criteria:
- pain and/or functional impairment;
- radiographic signs of osteolysis following wear of the implant components, or cortical reaction, or periprosthetic bone resorption;
- negative evaluation by the infectious disease specialist.
Exclusion
- presence of a sinus tract communicating with the arthroplasty;
- bacteria isolation from aspirates or blood cultures performed preoperatively;
- serum C-reactive protein higher than 10 mg/L;
- recurrent implant dislocations;
- prosthetic fracture;
- medical history for septic arthritis, osteomyelitis;
- infections in anatomic areas other than hip;
- antibiotic therapy in the 15 days prior to surgery (with the exception of preoperative antibiotic prophylaxis);
- chronic treatment with immunosuppressive drugs;
- medical contraindications for executing sample collection.
Key Trial Info
Start Date :
February 8 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 15 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04773054
Start Date
February 8 2022
End Date
February 15 2024
Last Update
March 20 2024
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136