CompletedNot Applicable

Infection Consortium Study#1

United States810 participantsStarted 2023-12-10

Plain-language summary

In this study, the Sponsor wants to evaluate the performance and accuracy of the PJI Panel compared to the currently used multiple-criterion scoring systems for the diagnosis of PJI.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Samples included in the Synovasure R\&D database from patients tested for PJI through the PJI Panel at CDL. Exclusion Criteria: * From Synovasure Database * Samples not submitted to CDL for PJI testing * Samples submitted to CDL from Institutions not participating in this study * Samples designated as being from anatomical locations other than "left hip", "left knee", "right hip", "right knee * Samples without SF-Cx results * Samples without SF-CRP results * Samples without AD results * Samples without WBC results * Samples without %PMN results * Samples with RBCs ≥ 1 million * Samples not meeting A280 specification for integrity: Remove A280 \< 0.342 and A280 \> 1.19 * Samples received more than four (4) days after aspiration * Patient age \< 18 From Institutional Medical Record * Patient who did not undergo surgical interventions after PJI Panel Testing * Synovasure testing performed less than 6 weeks after index surgery * Evidence of sinus tract communicating with the joint * Samples aspirated from patients using a spacer at the time of aspiration

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Positive/Negative Percent Agreement between PJI RISC Panel and Clinical Guidelines

Timeframe: 1 year

Trial details

NCT IDNCT06153446

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-09-04

View on ClinicalTrials.gov More PJI trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.