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One surgery enough? trial tests if extra procedure helps fight joint infections

NCT ID NCT05640336

Disease control Sponsor: Mayo Clinic 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 2 times

Summary

This study compares two standard treatments for acute infection after hip or knee replacement: a single surgery to clean the joint versus two planned surgeries. About 490 participants will be randomly assigned to one approach. The goal is to see which method better prevents the need for further surgery within one year.

What this could mean

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

Active substance
Surgical debridement (cleaning out infected tissue) and antibiotics
What this could lead to
If successful, this could show that a single surgery is as effective as two planned surgeries for treating joint infections, reducing patient burden and healthcare costs.
What could go wrong
This is a relatively early-stage trial with 490 participants, and results may not apply to all patients. There is a risk of infection returning regardless of the approach.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 490 people

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

Started

Mar 2023

Expected to finish

Mar 2032

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.

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 who speak English and are willing to sign the consent form * Patients with acute early postoperative infection (symptoms ≤ 4 weeks from surgery; symptoms \< 4 weeks in duration) and acute hematogenous infection (greater than 4 weeks from surgery; symptoms \< 3 weeks in duration) of a primary total knee or total hip arthroplasty, defined as: * A sinus communicating with the prosthesis OR * Two positive cultures obtained from the prosthesis OR * 4 of 5 criteria: Elevated ESR (\> 30mm/hr) and CRP (\> 10mg/L); Elevated synovial leukocyte count (\>3000 cells/μL) or change of ++ on; leukocyte esterase strip; Elevated synovial neutrophil percentage (\> 80%); One positive culture; Positive histological analysis of periprosthetic tissue (\> 5 neutrophils per high; Power field in 5 high power fields x 400). * OR Patient with an acute infection diagnosed clinically by an orthopedic surgeon treated with DAIR Exclusion Criteria: * Patients with a chronic PJI, defined as: presentation of symptoms \> 4 weeks in duration. * Revision surgery or previous two-stage reimplantation.

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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.

Periprosthetic 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

    2 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Minnesota

    Rochester, Minnesota, 55905, United States

More trials for these conditions

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