Joint Microbiome Study for the Knee

• Conditions: Knee Osteoarthritis; PJI
• Interventions: Diagnostic Test: Next Generation Sequencing

• Registration Number: NCT05254145
• Lead Sponsor: Rothman Institute Orthopaedics

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-02-15
• Last Update Submitted: 2022-02-15
• Study Start: 2022-02-20
• Study First Posted: 2022-02-24
• Last Update Posted: 2022-02-24
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group D	Next Generation Sequencing	This group will include participants undergoing knee revision surgery with no suspicion of infection (aseptic knee revision replacement)
Group A	Next Generation Sequencing	This group will include participants without an arthritic knee. These participants will be recruited from the Orthopedic Sports Medicine consultation
Group C	Next Generation Sequencing	This group will include participants undergoing a surgical procedure whose opposite knee has no history of arthritis
Group B	Next Generation Sequencing	This group will include participants undergoing primary knee arthroplasty (KA).
Group E	Next Generation Sequencing	This group will include participants undergoing knee revision with a known infection (septic knee revision replacements)

Primary Outcome Measures

Name	Time	Method
Determine the microbiome (bacterial composition) of the knee joint	3 days	Joint fluid taken from the operative knee during surgery will be analyzed using next generation sequencing (NGS).

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States