Status:
UNKNOWN
Joint Microbiome Study for the Knee
Lead Sponsor:
Rothman Institute Orthopaedics
Conditions:
Knee Osteoarthritis
PJI
Eligibility:
All Genders
18+ years
Brief Summary
Prosthetic joint infection (PJI) is a devastating complication following arthroplasty. An utmost effort has been done to clarify risk factors and microbiology of PJI. We now know the most frequent inf...
Eligibility Criteria
Inclusion
- All patients 18 years or older who give verbal and written informed consent for the retrieval of experimental samples and data collection.
- Group A: Subjects with lack of Osteoarthritis (OA) evidence, invasive examinations, minor procedures, cartilage damage, and/or synovitis in joints.
- Group B: Patients undergoing primary knee arthroplasty (partial or total).
- Group C: Contralateral non-affected (native) joint without knee arthroplasty, history of septic arthritis (SA), invasive examinations and/or minor procedures.
- Group D: Patients undergoing aseptic knee revision surgery.
- Group E: Patients undergoing septic knee revision surgery
Exclusion
- Withdrawal of informed consent, suspicion of PJI, surgical site infection (SSI) or septic arthritis (SA) before samples retrieval, use of antibiotics within 4 weeks before collecting the samples (not including perioperative antimicrobial prophylaxis), inflammatory arthritis, systemic rheumatic disorder, high risk of infection.
- Group A: History and/or suspicion before/at samples retrieval of SA in native joint.
- Group B: History and/or suspicion before/at samples retrieval of SSI or SA in the affected joint.
- Group C: No additional criterion.
- Group D: History and/or suspicion before/at samples retrieval of PJI, SSI, SA in the affected joint
- Group E: No additional criterion.
Key Trial Info
Start Date :
February 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05254145
Start Date
February 20 2022
End Date
February 28 2023
Last Update
February 24 2022
Active Locations (1)
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1
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107