Bone-Delivered antibiotics could spare joint infection patients from repeat surgeries
NCT ID NCT03713528
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2020
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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.
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The places running it
10 sites. The list below names each one and where it is.
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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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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
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Atrium Mercy Hospital
Charlotte, North Carolina, 28207, United States
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Cleveland Clinic Florida
Weston, Florida, 33331, United States
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New York University - Langone
New York, New York, 10279, United States
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Novant Health Charlotte Orthopedic Hospital
Charlotte, North Carolina, 28209, United States
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OrthoCarolina Research Institute/OrthoCarolina
Charlotte, North Carolina, 28207, United States
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Rush University
Chicago, Illinois, 60612, United States
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University of California, San Francisco
San Francisco, California, 94143, United States
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University of Florida
Gainesville, Florida, 32607, United States
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University of Nebraska
Omaha, Nebraska, 68105, United States
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University of Utah
Salt Lake City, Utah, 84112, United States
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Other studies related to the condition(s) this trial covers.
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- Emergency room study aims to improve diagnosis of septic arthritis
- Massive trial aims to slash infection risk in hip and knee replacements
- Virus cocktail takes on superbug in Last-Resort hip infection trial
- Which surgery works best for infected hip or knee replacements?
- Antibiotic side effects under the microscope in bone infection study