Intraosseous Antibiotics for Joint Infections

Enrolling by invitation at 9 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: OrthoCarolina Research Institute, Inc.

Must be taking: Vancomycin

Disqualifiers: Renal disease, Vascular disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering antibiotics directly into the bone during surgery to treat serious joint infections. Researchers aim to determine if this approach cleans infections more effectively than the usual process, potentially reducing the need for additional surgeries. It targets individuals who have undergone knee replacement surgery and are dealing with a joint infection sensitive to the antibiotic vancomycin. Participants should have experienced a knee infection within 90 days of their surgery or have certain infections resistant to standard removal procedures. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for intraoperative intraosseous vancomycin?

Research has shown that using vancomycin directly in the bone during surgery is generally safe for patients. This method helps prevent infections in surgeries like knee replacements. One study found that patients who received vancomycin this way experienced no major safety issues, and the treatment was well-tolerated.

Another study discovered that adding vancomycin directly into the bone to a common infection treatment plan effectively fought infections without causing significant side effects. This indicates the treatment is both effective and safe for patients with joint infections.

Overall, current research supports the safety of using vancomycin in the bone to treat joint infections, making it a promising option for improving patient outcomes. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike other treatments for joint infections, which often involve systemic antibiotic delivery, intraoperative intraosseous vancomycin is directly administered into the bone during surgery. This unique delivery method allows for higher local concentrations of the drug right at the infection site, potentially leading to more effective eradication of harmful bacteria. Researchers are excited about this approach because it targets the infection more precisely and may reduce the need for prolonged systemic antibiotic use, which can have widespread side effects.

What evidence suggests that intraoperative intraosseous vancomycin is effective for joint infections?

Studies have shown that intraosseous vancomycin, which participants in this trial will receive, can significantly enhance the treatment of infections around joint replacements. When combined with standard cleaning and treatment procedures, this method has led to better outcomes compared to using only IV antibiotics. Research indicates fewer cases of recurring infections with intraosseous vancomycin, potentially reducing the need for follow-up surgeries. This approach is safe and has demonstrated higher success rates in preventing infections for months to years after treatment. Consequently, patients may have a better chance of avoiding additional surgeries and experiencing longer-lasting relief. ^{1 2 6 7 8}

Who Is on the Research Team?

Thomas K. Fehring, MD

Principal Investigator

OrthoCarolina Research Institute, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I had an infection around my implant within 90 days after surgery.

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

Exclusion Criteria

Pregnant women

I cannot use a tourniquet because of my vascular disease.

Vancomycin-resistant organisms

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo irrigation and debridement with intraosseous vancomycin and receive at least 4 weeks of IV antibiotics

4 weeks

In-person surgical procedure and follow-up visits

Follow-up

Participants are monitored for recurrence of infection and effectiveness of treatment

1 year

Regular follow-up visits as per infectious disease specialist's guidance

What Are the Treatments Tested in This Trial?

Interventions

• Intraoperative Intraosseous Vancomycin

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

OrthoCarolina Research Institute, Inc.

Lead Sponsor

Trials

37

Recruited

6,000+

American Association of Hip and Knee Surgeons

Collaborator

Trials

4

Recruited

2,300+

American Association of Hip and Knee Surgeons

Collaborator

Trials

4

Recruited

2,300+

Citations

1. raaot.org.ar raaot.org.ar/index.php/AAOTMAG/article/download/2164/6322/

Intraosseous Vancomycin for Acute Periprosthetic Knee ... The aim of this study was to evaluate the efficacy and safety of DAIR supplemented with intraosseous vanco- mycin and modular component exchange ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40339929/

The AAHKS Best Podium Presentation Research Award Use of IO vancomycin infusion is a safe and effective alternative to IV administration for patients undergoing aseptic revision TKA.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40334953/

Superior Clinical Results With Intraosseous Vancomycin in ... Intraosseous vancomycin demonstrated superior clinical outcomes over IV vancomycin with a reduced incidence of PJI at 90-day, 1- and 2-year follow-up after ...

4. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(24)00477-7/fulltext

Low Risk of Periprosthetic Joint Infection After Aseptic ... Previous literature reports early periprosthetic joint infection (PJI) rates after aseptic rTKA to range from 3 to 9.4%.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03713528

Can Intraosseous Antibiotics Improve the Results of ... We ask if the use of intraosseous regional administration of antibiotics at the time of irrigation and debridement will improve the modest success of standard ...

6. boneandjoint.org.uk boneandjoint.org.uk/Article/10.1302/0301-620X.103B6.BJJ-2020-2278.R1

Results of debridement, antibiotics, and implant retention for ... The addition of intraosseous vancomycin to the Debridement, Antibiotics and Implant Retention procedure for acute infection is safe, with great infection non- ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8509941/

Intraosseous Regional Prophylactic Antibiotics Decrease the ... It is currently unknown whether the use of regional prophylactic antibiotics for primary TKA would result in a lower risk of prosthetic joint infection (PJI).

8. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-025-06257-2

Periprosthetic joint infection after arthroplasty: advances and ... Objective. To comprehensively analyze the prevention, diagnosis and management strategies of periprosthetic joint infections(PJIs), ...