Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation
Condition: Prosthetic Joint Infection
MeSH terms: Infections
Intervention: vancomycin hydrochloride and tobramycin sulfate
Intervention description: vancomycin hydrochloride and tobramycin sulfate via local irrigation
Intervention MeSH terms: Vancomycin; Tobramycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hip; Knee; Biofilm; Minimum-biofilm-eradication-concentration

Summary:

      Study Type

      Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial.

      Primary Study Objective

      The objective of the study is to determine the safety profile of local antibiotic irrigation
      for the treatment of PJI.

      Primary Outcome Measure

      The overall safety profile is characterized by assessing the incidence of adverse events
      (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and
      unexpected adverse reactions.

      Follow-up

      Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 12 months from
      initial surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years or greater

          -  Preoperative diagnosis of PJI of the hip or knee per the 2018 Definition of
             Periprosthetic Hip and Knee Infection

          -  Chronic PJI (symptoms lasting at least 4 weeks) per Tsukayama et al.

          -  Medical clearance for surgery

          -  Physical and mental ability and willingness to comply with the protocol, including the
             ability to read and complete required forms, and willingness and ability to adhere to
             the scheduled follow-up visits and requirements of the protocol

        Exclusion Criteria:

          -  Late acute hematogenous infection per Tsukayama et al.

          -  Patients for whom a two-stage exchange arthroplasty is not indicated

          -  Sepsis

          -  Previously failed single- or two-stage revision arthroplasty for PJI (aseptic
             revision, polyethylene liner exchange, and/or irrigation and debridement with
             component retention is allowed)

          -  Patients with PJI of more than one joint

          -  Patients on chronic antibiotic therapy (≥ 6 months duration)

          -  Patients who require therapeutic anticoagulation

          -  Patients on antiplatelet therapy for whom withholding antiplatelet therapy for any
             amount of time is contraindicated

          -  Patients with renal insufficiency/failure (serum creatinine ≥ 2.0 mg/dl)

          -  Patients with uncontrolled diabetes, defined as: hemoglobin A1C levels > 8.0%

          -  Patients on immunosuppressive therapy, chemotherapy for malignant disease, or
             glucocorticoid therapy (e.g. prednisone ≥ 10 mg/day).

          -  Patients with immunodeficiency (e.g., splenectomy; sickle cell anemia; Stage 3 HIV;
             primary humoral, bone marrow, or other transplantation.)

          -  Anticipated or potential patient relocation that may interfere with follow-up
             examinations

          -  Allergy to vancomycin HCl or tobramycin sulfate (Note: prior history of Red Man's
             syndrome is not considered an allergy)

          -  Patients who are pregnant or planning to become pregnant

          -  Patients in whom negative pressure wound therapy is contraindicated

          -  Patients infected with pathogens that are not considered susceptible to vancomycin HCl
             or tobramycin sulfate, as per the Investigator's opinion

          -  Breastfeeding at screening visit

          -  Patients who are prisoners

          -  Participation in another clinical trial of another Investigational Drug or
             Investigational Device within the past 30 days