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New blood and joint fluid tests aim to spot hidden infections after joint replacement

NCT ID NCT04858217

Diagnosis Sponsor: Istituto Ortopedico Rizzoli Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looks at whether combining blood and joint fluid tests can more accurately diagnose infections in people who need a second hip or knee replacement. Researchers will test 270 patients and compare the accuracy and cost of different markers. The goal is to help doctors decide the best surgical approach faster and avoid unnecessary treatments.

What this could mean

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

What this could lead to
If successful, this could lead to faster, more accurate diagnosis of joint replacement infections, helping doctors choose the right surgery sooner.
What could go wrong
This is an observational study, not a treatment trial. The markers may not prove reliable enough to change current practice, and results may not apply to all patients.

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

About 270 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

A maximum number of n = 270 patients who will have to undergo hip or knee prosthetic revision surgery will be enrolled, of which n = 54 for late infection ascertained by previous microbiological analyzes, and n = 216 for prosthetic failure not from infection. Patients will be enrolled in the clinical study only after having signed and dated personally or by the patient's legal representative, the written informed consent. Therefore, enrollment in the study (exclusively of a diagnostic type) will not in any case influence the established diagnostic and therapeutic path.

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: * Patients requiring hip or knee replacement surgery: i) for 'late' joint prosthesis infection, present for at least 90 days from the date of the arthroplasty (first surgical phase); II) for non-infectious causes (mobilization, wear, instability, misalignment, adverse reactions to local tissues or other aseptic causes), also present for at least 90 days, and which have not had other re-operations on the same joint, and which will be a one-step review; * Previous clinical data and laboratory and radiological examinations available. Exclusion Criteria: * Patients affected by 'early' joint prosthesis infection, with clinical symptom latency of less than 90 days (in this specific subset of patients there is in fact still considerable heterogeneity and little consensus about the diagnostic levels of white blood cell count and percentage of neutrophils). * Patients suffering from joint prosthesis infection involving joints other than the hip or knee. * Severe cognitive impairment or psychiatric disorders; * Pregnant women.

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Conditions

The condition(s) this trial relates to.

periprosthetic joint infection

As listed by the trial registrant

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

Prosthetic-joint infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS Istituto Ortopedico Rizzoli

    RECRUITING

    Bologna, 40134, Italy

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