Intraosseous Antibiotics for Joint Infections

Recruiting 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

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Purpose of Study: In order to improve upon the variable results seen in irrigation and debridement for periprosthetic infection, 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 irrigation and debridement. We will use the existing literature on standard irrigation and debridement procedures to compare with the results of the irrigation and debridement with the use of intraosseous antibiotics. Impact Question: How will this study benefit the patient? Currently when an I\&D fails, the patient needs to undergo two more major procedures: 1) implant removal and 2) reimplantation of the prosthesis. Any improvement in the results of a standard irrigation and debridement procedure may decrease the number of patients having to go through further extensive procedures to cure their infection.

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.

Is intraosseous vancomycin safe for use in humans?

Intraosseous vancomycin has been used in surgeries like knee and spinal operations, and studies suggest it is generally safe with a low rate of complications. Some rare side effects have been reported, such as temporary hearing loss and kidney issues, but these are uncommon. ^{1 2 3 4 5}

How does intraosseous antibiotic treatment differ from other treatments for joint infections?

Intraosseous antibiotic treatment is unique because it delivers antibiotics directly into the bone, achieving higher local concentrations and reducing systemic side effects compared to traditional intravenous methods. This approach is particularly effective in preventing infections after surgeries like total knee arthroplasty, where it can provide better protection against resistant bacteria. ^{2 4 6 7 8}

What data supports the effectiveness of the drug Intraoperative Intraosseous Vancomycin for joint infections?

Research shows that using vancomycin directly in the bone (intraosseous) during knee surgery can lead to higher antibiotic levels in the tissues compared to traditional methods, which may help prevent infections more effectively and with fewer side effects. ^{1 2 6 8 9}

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. England pubmed.ncbi.nlm.nih.gov

Intraosseous regional prophylaxis in total knee arthroplasty. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical outcome evaluation of intraosseous vancomycin in total knee arthroplasty. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Intraosseous Regional Administration of Prophylactic Antibiotics in Total Knee Arthroplasty. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Intraarticular vancomycin decreased the risk of acute postoperative periprosthetic joint infection without increasing complication in primary total joint arthroplasty-a prospective study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of intrawound vancomycin in primary hip and knee arthroplasty. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Complications from the use of intrawound vancomycin in lumbar spinal surgery: a systematic review. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Effect of Intra-wound Vancomycin for Spinal Surgery: A Systematic Review and Meta-analysis. [2020]

8. Chile pubmed.ncbi.nlm.nih.gov

Should we add vancomycin antibiotic powder to prevent post operative infection in spine surgery? - First update. [2018]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Operative treatment of osseous and osteoarticular paronychia by applying a closed suture to the wound and by prolonged intra-osseous administration of antibiotics]. [2006]