Joint Microbiome Study for the Knee

Study Overview
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Brief Summary
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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 infecting microorganisms are members of the skin microbiome. These microorganisms are thought to get into the joint and infect the prosthesis during the peri-operative and/or post-operative period. Nevertheless, recent studies have suggested, bacteria may be present in the joint even before the first incision, suggesting the existence of a joint microbiome. Therefore, we aimed to determine the bacterial composition from different knee conditions.

Official Title
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Insight of Joint Microbiome From Different Knee Conditions.

Conditions
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Knee Osteoarthritis, PJI

Intervention / Treatment
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* Diagnostic Test: Next Generation Sequencing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>This group will include participants without an arthritic knee. These participants will be recruited from the Orthopedic Sports Medicine consultation | Diagnostic Test: Next Generation Sequencing<br>* During the participants surgical procedure, a total of 3 ml of synovial fluid (joint fluid collected from the knee) will be collected per joint. Upon collection, the samples will be deidentified, stored on ice and shipped with a study ID number to MicroGenDx for Next Generation Sequencing.<br>|
| Group B<br>This group will include participants undergoing primary knee arthroplasty (KA). | Diagnostic Test: Next Generation Sequencing<br>* During the participants surgical procedure, a total of 3 ml of synovial fluid (joint fluid collected from the knee) will be collected per joint. Upon collection, the samples will be deidentified, stored on ice and shipped with a study ID number to MicroGenDx for Next Generation Sequencing.<br>|
| Group C<br>This group will include participants undergoing a surgical procedure whose opposite knee has no history of arthritis | Diagnostic Test: Next Generation Sequencing<br>* During the participants surgical procedure, a total of 3 ml of synovial fluid (joint fluid collected from the knee) will be collected per joint. Upon collection, the samples will be deidentified, stored on ice and shipped with a study ID number to MicroGenDx for Next Generation Sequencing.<br>|
| Group D<br>This group will include participants undergoing knee revision surgery with no suspicion of infection (aseptic knee revision replacement) | Diagnostic Test: Next Generation Sequencing<br>* During the participants surgical procedure, a total of 3 ml of synovial fluid (joint fluid collected from the knee) will be collected per joint. Upon collection, the samples will be deidentified, stored on ice and shipped with a study ID number to MicroGenDx for Next Generation Sequencing.<br>|
| Group E<br>This group will include participants undergoing knee revision with a known infection (septic knee revision replacements) | Diagnostic Test: Next Generation Sequencing<br>* During the participants surgical procedure, a total of 3 ml of synovial fluid (joint fluid collected from the knee) will be collected per joint. Upon collection, the samples will be deidentified, stored on ice and shipped with a study ID number to MicroGenDx for Next Generation Sequencing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the microbiome (bacterial composition) of the knee joint | Joint fluid taken from the operative knee during surgery will be analyzed using next generation sequencing (NGS). | 3 days |