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Joint Microbiome Study for the Knee

Insight of Joint Microbiome From Different Knee Conditions.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05254145
Enrollment
100
Registered
2022-02-24
Start date
2022-02-20
Completion date
2023-02-28
Last updated
2022-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis, PJI

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.

Interventions

DIAGNOSTIC_TESTNext 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.

Sponsors

Rothman Institute Orthopaedics
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Determine the microbiome (bacterial composition) of the knee joint3 daysJoint fluid taken from the operative knee during surgery will be analyzed using next generation sequencing (NGS).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026