Joint Microbiome Study for the Knee

Insight of Joint Microbiome From Different Knee Conditions.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Knee Osteoarthritis; PJI
• Intervention / Treatment: Diagnostic test: Next Generation Sequencing

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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 B; This group will include participants undergoing primary knee arthroplasty (KA).	Diagnostic test: Next Generation Sequencing; 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 C; This group will include participants undergoing a surgical procedure whose opposite knee has no history of arthritis	Diagnostic test: Next Generation Sequencing; 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 D; This group will include participants undergoing knee revision surgery with no suspicion of infection (aseptic knee revision replacement)	Diagnostic test: Next Generation Sequencing; 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 E; This group will include participants undergoing knee revision with a known infection (septic knee revision replacements)	Diagnostic test: Next Generation Sequencing; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (Anticipated): February 20, 2022
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: JPAR22D.042

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No