Joint Microbiome Study for the Knee

Knee Osteoarthritis Clinical Trial

Official title:

Insight of Joint Microbiome From Different Knee Conditions.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05254145
• Other study ID #: JPAR22D.042
• Status: Enrolling by invitation
• Start date: February 20, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: February 2022
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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