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Knee surgery infection study: one antibiotic dose may be enough

NCT ID NCT03283878

Disease control Sponsor: Duke University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Updated 2 times

Summary

This study looked at how to best use antibiotics to prevent infections in people having knee replacement surgery. About 1,770 adults were split into groups that got antibiotics either just before surgery or for a full day after. The goal was to see if a single dose works as well as longer treatment, which could reduce side effects and costs.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1,770 people

The number who actually took part.

Started

Oct 2017

Finished

Aug 2025

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: * Patient is ≥ 18 years of age * Patient has no open wounds on operative leg * Patient is scheduled to undergo elective total knee arthroplasty for posttraumatic, osteoarthritis, avascular necrosis, and/or inflammatory arthritis * Patient does not have active infection on the operative leg, the operative joint * Patient is willing to cooperate and follow study protocol and visit schedule Exclusion Criteria: * Patient is ≤ 18 years of age * Patient is pregnant * Patient is unable to provide written consent * Patient has psychiatric disorder that precludes safe study participation or that necessitates confinement in a custodial environment at home or in a chronic care facility * Patient has traumatic injury that requires emergent or urgent total knee arthroplasty (e.g. fracture) * Patient has active infections in the operative leg/joint * Patient has severe dementia * Suspicion of illicit drug abuse by patient. Patients who use prescription cannabinoids are not excluded from enrollment. * ASA score of 5 \& 6 * No application of topical antibiotic powder such as vancomycin or antibiotic beads in surgical wound * Intra-operative re-dosing other than specified re-dosing intervals or without excessive blood loss (\<1500mL) * History of prior native septic knee arthritis

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Conditions

The condition(s) this trial relates to.

arthritic joint disease osteoarthritis susceptibility 6 osteoarthritis, knee periprosthetic joint infection prevention target

As listed by the trial registrant

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

Antibiotic prophylaxis Arthropathy of knee

Contacts and locations

Locations

  • Augusta Health

    Fishersville, Virginia, 22939, United States

  • BaylorScott&White Research Institute

    Temple, Texas, 76508, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Duke University Medical Center

    Durham, North Carolina, 27703, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Mississippi Bone and Joint Clinic

    Starkville, Mississippi, 39759, United States

  • NYU School of Medicine

    New York, New York, 10003, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Rothman Institute

    Philadelphia, Pennsylvania, 19107, United States

  • University Of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University Orthopaedic Associates, LLC

    Somerset, New Jersey, 08873, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Maryland St. Joseph Medical Center & Orthopedic Associates

    Towson, Maryland, 21204, United States

  • University of South Carolina

    Columbia, South Carolina, 29208, United States

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