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Joint Microbiome Study for the Knee

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05254145
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Rothman Institute Orthopaedics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Knee Osteoarthritis, PJI
Arms & Interventions

Arms

: Group A

This group will include participants without an arthritic knee. These participants will be recruited from the Orthopedic Sports Medicine consultation

: Group B

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

: Group C

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

: Group D

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

: Group E

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

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rothman Orthopaedic Institute, Philadelphia, Pennsylvania

Status

Address

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107

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