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Bone-Delivered antibiotics could spare joint infection patients from repeat surgeries

NCT ID NCT03713528

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving antibiotics directly into the bone during a standard cleaning surgery can better control joint infections and reduce the need for additional major surgeries. About 100 adults with infected knee or hip replacements will receive this targeted antibiotic approach and be followed for one year. The goal is to improve infection cure rates and avoid implant removal.

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

About 100 people

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

Started

Jan 2020

Expected to finish

Jun 2027

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

Accepted

You do not need to have the condition being studied to take part.

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 (to be completed at time of consent) I. Acute perioperative periprosthetic infection in the first 90 days following primary surgery OR, II. Acute hematogenous infection with symptoms less than four weeks OR, III. Any patient with a chronic periprosthetic knee infection, or a prosthetic knee that is considered unresectable due to the presence of extremely difficult to extract implants such as cones/sleeves/or long cemented or cementless stems and indicated for an irrigation debridement procedure. IV. Patients indicated for an irrigation debridement procedure of a knee periprosthetic knee joint infection as defined by the inclusion criteria noted above with a gram positive organism susceptible to vancomycin, defined as: 1. A sinus communicating with the prosthesis, OR 2. Two positive cultures obtained from the prosthesis, OR 3. 3 of 5 criteria: i. Elevated ESR (\>30mm/hr) and CRP (\>10mg/L) ii. Elevated synovial leukocyte count (\>3000 cells/µL) or change of ++ on leukocyte esterase strip iii. Elevated synovial neutrophil percentage (\>80%) iv. One positive culture v. Positive histological analysis of periprosthetic tissue (\>5 neutrophils per high power field in 5 high power fields x400) We understand that on occasion, irrigation \& debridement is performed emergently, therefore enrollment may continue without all laboratory/cultures completed. All inclusion criteria in this situation will be confirmed postoperatively. V. Any patient \>18 years old Exclusion Criteria I. Surgical wound that cannot be closed. II. Patients with an acute PJI greater than 90 days following primary surgery (using standard implants). III. Hematogenous infection with symptoms greater than four weeks IV. Know hypersensitivity to Vancomycin V. Major Renal disease defined as creatinine \> 2.0 (See previous comments, No Red Man syndrome in 2 subsequent studies on intraosseous vancomycin in revision TKA and High BMI patients respectively (9). Additionally, systemic levels were 8 times lower with intraosseous antibiotics than IV Vancomycin.) VI. Unable to use a tourniquet due to vascular disease VII. Pregnant women VIII. Allergy to antibiotic Screen Failure (following initial procedure): IX. Culture negative infections whereby the infecting organism was not identified OR X. Vancomycin-resistant organisms

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    10 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.

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  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

  • Atrium Mercy Hospital

    Charlotte, North Carolina, 28207, United States

  • Cleveland Clinic Florida

    Weston, Florida, 33331, United States

  • New York University - Langone

    New York, New York, 10279, United States

  • Novant Health Charlotte Orthopedic Hospital

    Charlotte, North Carolina, 28209, United States

  • OrthoCarolina Research Institute/OrthoCarolina

    Charlotte, North Carolina, 28207, United States

  • Rush University

    Chicago, Illinois, 60612, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Florida

    Gainesville, Florida, 32607, United States

  • University of Nebraska

    Omaha, Nebraska, 68105, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

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