Joint Microbiome Study for the Knee

Rothman Institute Orthopaedics

Status: Unknown

Conditions: PJI; Knee Osteoarthritis

Treatments: Diagnostic Test: Next Generation Sequencing

Study type: Observational

Funder types: Other

Identifiers

NCT05254145

JPAR22D.042

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

100 participants in 5 patient groups

Group A

Description:

This group will include participants without an arthritic knee. These participants will be recruited from the Orthopedic Sports Medicine consultation

Treatment:

Diagnostic Test: Next Generation Sequencing

Group B

Description:

This group will include participants undergoing primary knee arthroplasty (KA).

Treatment:

Diagnostic Test: Next Generation Sequencing

Group C

Description:

This group will include participants undergoing a surgical procedure whose opposite knee has no history of arthritis

Treatment:

Diagnostic Test: Next Generation Sequencing

Group D

Description:

This group will include participants undergoing knee revision surgery with no suspicion of infection (aseptic knee revision replacement)

Treatment:

Diagnostic Test: Next Generation Sequencing

Group E

Description:

This group will include participants undergoing knee revision with a known infection (septic knee revision replacements)

Treatment:

Diagnostic Test: Next Generation Sequencing