Knee OsteoarthritisNCT05254145
Joint Microbiome Study for the Knee
An observational study of Knee Osteoarthritis and PJI, run by Rothman Institute Orthopaedics at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, PJI
- What is being tested?
- Next Generation Sequencing
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2022to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: 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.
- Conditions
- Knee Osteoarthritis, PJI
- Being tested
- Next Generation Sequencing
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next Generation SequencingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | This group will include participants without an arthritic knee. These participants will be recruited from the Orthopedic Sports Medicine consultation Receives: Diagnostic Test: Next Generation Sequencing | |
| Group B | This group will include participants undergoing primary knee arthroplasty (KA). Receives: Diagnostic Test: Next Generation Sequencing | |
| Group C | This group will include participants undergoing a surgical procedure whose opposite knee has no history of arthritis Receives: Diagnostic Test: Next Generation Sequencing | |
| Group D | This group will include participants undergoing knee revision surgery with no suspicion of infection (aseptic knee revision replacement) Receives: Diagnostic Test: Next Generation Sequencing | |
| Group E | This group will include participants undergoing knee revision with a known infection (septic knee revision replacements) Receives: Diagnostic Test: Next Generation Sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start20 Feb 2022 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254145
- Sponsor's protocol ID
- JPAR22D.042
- Status last verified
- Feb 2022
- First submitted
- 15 Feb 2022
- Last updated
- 24 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insight of Joint Microbiome From Different Knee Conditions.
- ClinicalTrials.gov ID
- NCT05254145
- Acronym / sponsor ID
- JPAR22D.042
- Conditions
- Knee Osteoarthritis, PJI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 20 Feb 2022 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Diagnostic Test: Next Generation SequencingThis group will include participants without an arthritic knee. These participants will be recruited from the Orthopedic Sports Medicine consultation |
| Group B | – | Diagnostic Test: Next Generation SequencingThis group will include participants undergoing primary knee arthroplasty (KA). |
| Group C | – | Diagnostic Test: Next Generation SequencingThis group will include participants undergoing a surgical procedure whose opposite knee has no history of arthritis |
| Group D | – | Diagnostic Test: Next Generation SequencingThis group will include participants undergoing knee revision surgery with no suspicion of infection (aseptic knee revision replacement) |
| Group E | – | Diagnostic Test: Next Generation SequencingThis group will include participants undergoing knee revision with a known infection (septic knee revision replacements) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Next Generation SequencingDuring 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. | Diagnostic test | Group A, Group B, Group C, Group D, Group E |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and PJI, run by Rothman Institute Orthopaedics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the microbiome (bacterial composition) of the knee joint (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.