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Knee infection breakthrough? one surgery may replace two

NCT ID NCT06293352

Disease control Sponsor: Northwestern University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 25, 2026 · Updated 3 times

Summary

This study tests whether a single surgery to replace an infected artificial knee works as well as the standard two-surgery approach. About 153 patients with a chronic knee infection will be randomly assigned to one of the two treatments. Researchers will track pain, function, and satisfaction for 5 years to see which method patients prefer and which provides better long-term results.

What this could mean

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

Active substance
antibiotic cement spacer
What this could lead to
If successful, this study could show that a single surgery works as well as two surgeries for treating knee infections, saving patients time and improving knee function sooner.
What could go wrong
This is a mid-stage study with 153 participants, so results may not apply to everyone. The one-stage spacer may need replacement sooner than a standard artificial knee.

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 153 people

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

Started

Aug 2024

Expected to finish

Aug 2028

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 diagnosed with a chronic periprosthetic joint infection after a primary total knee arthroplasty with plan for explant and placement of an antibiotic spacer * PJI defined according to Musculoskeletal Infection Society (MSIS) 2018 Consensus Criteria Exclusion Criteria: * Patients who are unable to consent * Infection at site of revision TKA * Soft tissue envelope compromise * Allergies to study materials (cement, vancomycin, tobramycin) * Incompetent extensor mechanism * Extensive bone loss Randomization-specific exclusion criteria * Extensive soft tissue defect * Extensor mechanism compromise

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Conditions

The condition(s) this trial relates to.

bacterial arthritis infective arthritis periprosthetic joint infection

As listed by the trial registrant

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

Arthroplasty complications Arthroplasty, replacement, knee Joint infection Knee infection 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

  • Northwestern Medicine

    RECRUITING

    Chicago, Illinois, 60611, United States

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