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Intraosseous Antibiotics for Joint Infections

Phase 4

Waitlist Available

Led By Thomas Fehring, MD

Research Sponsored by OrthoCarolina Research Institute, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients indicated for an irrigation debridement procedure of a knee periprosthetic knee joint infection with a gram positive organism susceptible to vancomycin

Acute hematogenous infection with symptoms less than four weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will study whether using intraosseous regional administration of antibiotics at the time of irrigation and debridement will improve the success rate of the standard irrigation and debridement procedure for periprosthetic infection.

Who is the study for?

This trial is for adults over 18 with a knee joint infection after surgery, within the first 90 days or with symptoms under four weeks. It includes those who can't have their prosthetic knee removed due to complex implants and whose infections are treatable by vancomycin. Excluded are individuals with severe kidney disease, known allergy to vancomycin, pregnant women, and cases where the infecting organism is unknown or resistant to vancomycin.Check my eligibility

What is being tested?

The study tests if using intraosseous antibiotics (vancomycin) directly into the bone during irrigation & debridement improves outcomes compared to standard procedures alone. The goal is to see if this method reduces further major surgeries needed when standard treatment fails.See study design

What are the potential side effects?

Potential side effects may include local reactions at the administration site, allergic responses in those sensitive to vancomycin (though rare), and possibly systemic effects like 'Red Man Syndrome', although previous studies suggest lower risks with intraosseous delivery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need a knee cleaning surgery for an infection sensitive to vancomycin.

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I have had symptoms of a blood infection for less than 4 weeks.

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I have a long-term infection in my knee replacement that's hard to remove and need a cleaning procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recurrence of Infection

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

The treatment group includes any patient with an acute perioperative periprosthetic infection, acute hematogenous infection, or unresectable infection with a gram positive organism sensitive to vancomycin and treated with intraoperative intraosseous vancomycin. Additionally, patients will be treated with at least 4 weeks of IV antibiotics under guidance of an infectious disease specialist, and indefinite antibiotic chronic suppression.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

OrthoCarolina Research Institute, Inc.Lead Sponsor

34 Previous Clinical Trials

5,831 Total Patients Enrolled

American Association of Hip and Knee SurgeonsUNKNOWN

1 Previous Clinical Trials

8,000 Total Patients Enrolled

Thomas Fehring, MDPrincipal InvestigatorOrthoCarolina Research Institute, Inc.

3 Previous Clinical Trials

233 Total Patients Enrolled

Media Library

Treatment Group Clinical Trial Eligibility Overview. Trial Name: NCT03713528 — Phase 4

Joint Infections Research Study Groups: Treatment Group

Joint Infections Clinical Trial 2023: Treatment Group Highlights & Side Effects. Trial Name: NCT03713528 — Phase 4

Treatment Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT03713528 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in this research trial?

"At this juncture, no more participants are being accepted into this medical trial. The study was first posted to clinicaltrials.gov on the 14th of January 2020 and last updated at the end of March in 2022. Alternatively, there are presently 6 trials regarding joint infections that accept new volunteers as well 55 studies involving similar treatments recruiting patients now."

Answered by AI

In what situations has this treatment been found to be most efficacious?

"Treatment for staphylococcal infections, infection induced by staphylococci and enterocolitis due to Staphyloccus aureus can be achieved with this medication."

Answered by AI

Are there any more openings for participants in this clinical experiment?

"Unfortunately, no further participants are being accepted for this medical trial. It was initially posted on January 14th of 2020 and most recently modified in March 31st 2022. If you're interested in other trials related to joint infections, there are currently 6 studies looking to recruit patients whilst 55 more may be enrolling new members soon."

Answered by AI

How many healthcare sites in the United States are presently conducting this investigation?

"There are 13 sites participating in this trial, including New york University - Langone, situated in the capital of the Empire State; University of Florida located in Gainesville; and Rush University found within Chicago's windy boundaries."

Answered by AI

To what degree is this treatment beneficial and secure for people?

"There is substantial evidence of safety, so this treatment has been assigned a ranking of 3 on our scale. This evaluation was made due to the fact that it's currently undergoing Phase 4 clinical trials and thus has already received regulatory approval."

Answered by AI

Could you please provide a comprehensive overview of all the investigations conducted concerning this particular treatment?

"The initial research into this treatment was conducted a decade ago at Sacramento Pediatric Gastroenterology. There are currently 151 finished clinical trials, with 55 ongoing studies primarily occuring in New york City."

Answered by AI

Recent research and studies

The Journal of ArthroplastyJournal

The AAHKS Clinical Research Award: Intraosseous Regional Prophylaxis Provides Higher Tissue Concentrations in High BMI Patients in Total Knee Arthroplasty: A Randomized Trial

Chin, Seung Joon, Grant A. Moore, Mei Zhang, Henry D. Clarke, Mark J. Spangehl, and Simon W. Young. 2018. “The AAHKS Clinical Research Award: Intraosseous Regional Prophylaxis Provides Higher Tissue Concentrations in High BMI Patients in Total Knee Arthroplasty: A Randomized Trial”. The Journal of Arthroplasty. Elsevier BV. doi:10.1016/j.arth.2018.03.013.

The Journal of ArthroplastyJournal

Infected Total Knee Arthroplasty Treated by Arthroscopic Irrigation and Débridement

Waldman, Barry J, Emmanuel Hostin, Michael A Mont, and David S Hungerford. 2000. “Infected Total Knee Arthroplasty Treated by Arthroscopic Irrigation and Débridement”. The Journal of Arthroplasty. Elsevier BV. doi:10.1054/arth.2000.4637.

The Journal of ArthroplastyJournal

One-stage Vs Two-stage Exchange

Lichstein, Paul, Thorsten Gehrke, Adolph Lombardi, Carlo Romano, Ian Stockley, George Babis, Jerzy Bialecki, et al.. 2014. “One-stage Vs Two-stage Exchange”. The Journal of Arthroplasty. Elsevier BV. doi:10.1016/j.arth.2013.09.048.

Clinical Orthopaedics & Related ResearchJournal