A Randomized Controlled Trial of Alternating Irrigation of Vancomycin HCl and Tobramycin Sulfate in Patients Undergoing Two-Stage Exchange Arthroplasty for Periprosthetic Joint Infection of Hip or Knee.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Joint Infection
  • Age: Between 22 years - 110 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Scheduled two-stage exchange arthroplasty due to hip or knee PJI
    2. Provide written informed consent
    3. Medical clearance for surgery
    4. Preoperative diagnosis of Periprosthetic joint infection (PJI) of the hip or knee

You may not be eligible for this study if the following are true:

    1. Patients with 2 or more prior one-stage or two-stage exchange arthroplasties of the infected joint
    2. Patients who have been diagnosed with an acute PJI as a result of a total joint arthroplasty which took place within the last 4 weeks
    3. Had bacteremia or positive bacterial blood culture in the last 6 months
    4. Concurrent PJI of more than one joint
    5. Ongoing active infection of an intravenous (IV) site
    6. Requires long-term anticoagulation or antiplatelet therapy, and for whom bridging or withholding therapy is not recommended based on the individual's clinical condition
    7. Advanced renal insufficiency
    8. On chemotherapy for malignant disease
    9. On systemic glucocorticoid therapy
    10. Patients with immunodeficiency
    11. Patients who have an allergy to vancomycin HCl or tobramycin sulfate
    12. Have an allergy to titanium, titanium alloys, polymethylmethacrylate or polyurethane
    13. Pregnant or planning to become pregnant in the next 12 months or breastfeeding
    14. Patients in whom Negative pressure wound therapy (NPWT) is contraindicated
    15. Patients with a Periprosthetic joint infection (PJI) pathogen that is not considered susceptible to vancomycin HCl or tobramycin sulfate, per the Principal Investigator's (PI's) opinion, including fungal infection
    16. Have a "megaprosthesis" addressing a large skeletal defect in the infected joint
    17. Planned surgical procedure within 6 months of enrollment that can impact the conduct of the study
    18. Currently abusing drugs or alcohol or have been in treatment for substance abuse within the past year
    19. Patients who are incarcerated or are facing impending incarceration
    20. Patients with any medical condition, including schizophrenia or another psychiatric disorder with hallucinations and/or delusions, that would interfere with the interpretation of the study results, the conduct of the study, or patient participation would not be in the best interest of the patient in the opinion of the Study Site PI
    21. Patients who have participated in another clinical study of another investigational drug or investigational device within the past 30 days
    22. Patients who are judged by the PI to be unsuitable for the study

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