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Clinical Trials/NCT05254145
NCT05254145
Unknown
Not Applicable

Insight of Joint Microbiome From Different Knee Conditions.

Rothman Institute Orthopaedics1 site in 1 country100 target enrollmentFebruary 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Rothman Institute Orthopaedics
Enrollment
100
Locations
1
Primary Endpoint
Determine the microbiome (bacterial composition) of the knee joint
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 20, 2022
End Date
February 28, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Determine the microbiome (bacterial composition) of the knee joint

Time Frame: 3 days

Joint fluid taken from the operative knee during surgery will be analyzed using next generation sequencing (NGS).

Study Sites (1)

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