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Joint infection diagnosis: new test matches up against standard guidelines

NCT ID NCT06153446

Diagnosis Sponsor: Zimmer Biomet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at a new test called Synovasure that checks joint fluid for signs of infection after hip or knee replacement. Researchers compared its accuracy to current clinical guidelines using 810 stored samples. The goal was to see if the new test agrees with standard methods for diagnosing periprosthetic joint infection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Synovasure Comprehensive Infection Panel (diagnostic test on synovial fluid)
What this could lead to
If accurate, this test could help doctors diagnose joint infections faster and more reliably after hip or knee replacement.
What could go wrong
This is a completed study using stored samples, not a real-time trial. The test's real-world benefit depends on how it performs in everyday clinical practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

810 people

The number who actually took part.

Started

Dec 2023

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patient tested for PJI through the PJI Panel at CD Laboratories (CDL).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

juvenile polyposis syndrome periprosthetic joint infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PJI

Contacts and locations

Locations

  • Rothman Orthopedic Institute

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.