Joint Microbiome Study for the Knee

NCT05254145 | Unknown

• 1 other identifier: JPAR22D.042
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; PJI

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

Group A

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

Group B

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

Diagnostic Test: Next Generation Sequencing

Group C

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

Diagnostic Test: Next Generation Sequencing

Group D

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

Diagnostic Test: Next Generation Sequencing

Group E

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

Diagnostic Test: Next Generation Sequencing

Interventions

Next Generation Sequencing DIAGNOSTIC_TEST

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.

Group A; Group B; Group C; Group D; Group E

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited preoperatively during their elective procedure scheduling visit (diagnostic/treatment algorithm for group A or surgery for groups B-E, accordingly). Patients presenting for Orthopedic Sports Medicine consultation (group A), with end-stage knee osteoarthritis who are candidates for TKA (group B/C), patients with a TKA who require an aseptic knee revision surgery (group C/D), or those patients complicated by PJI (group E), and who agree to participate in the study will undergo the informed consent process

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 24, 2022
• Study Start: February 20, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: February 24, 2022

Record last verified: 2022-02

Locations

US (1)