Clinical Trials

Inclusion Criteria:

• Scheduled for two-stage exchange arthroplasty due to hip or knee periprosthetic joint infection (PJI).
• Signed informed consent.
• 22 to 84 years of age (inclusive).
• Medical clearance for surgery.
• Preoperative diagnosis of PJI of the hip or knee per the International Consensus.
• Meeting of Musculoskeletal Infection (ICMMI) 2018 definition of Periprosthetic Hip and Knee Infection.

Exclusion Criteria:

• Patients with 2 or more prior exchange arthroplasties (septic or aseptic) of the infected joint. Exchange of modular components only is not considered an exchange arthroplasty.
• Patients with 2 or more prior failed spacers for PJI.
• Patients for whom a Stage 2 procedure within one year is contraindicated.
• Patients with bacteremia or positive bacterial blood culture in the last 30 days.
• Patients with concurrent PJI of more than one joint.
• Patients with ongoing active infection of an IV site.
• Patients who require long-term anticoagulation or antiplatelet therapy, and for whom bridging or withholding therapy is not recommended based on the individual’s clinical condition.
• Patients with advanced renal insufficiency (i.e., CKD Stage 4 or 5 or patients with an estimated glomerular filtration rate (eGFR) 10 mg/day or equivalent).
• Patients who are immunodeficient (e.g., splenectomy, sickle cell anemia, Stage 3 HIV infection, primary immunodeficiency disease), except patients who are immunodeficient due to immunosuppressive therapy.
• Patients who have an allergy to vancomycin hydrochloride or tobramycin sulfate (Note: prior history of red man syndrome is not considered an allergy);
• Patients who have an allergy to titanium, titanium alloys, polymethylmethacrylate, polyethylene, or polyurethane.
• Patients who are pregnant or planning to become pregnant in the next 12 months.
• Patients with a fungal PJI as determined by fluid and/or tissue culture.
• Patients who have a skeletal defect of greater than 150 mm in length in the tibia or femur of the infected joint.
• Patients who have a planned surgical procedure within 6 months of enrollment that can impact the conduct of the study.
• Patients who are breastfeeding.
• Patients who are incarcerated or are facing impending incarceration.
• Patients who have been in treatment or referred to treatment for substance abuse within the past year.
• Patients who have 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 study participation would not be in the best interest of the patient in the opinion of the Study Site PI.
• Patients who will participate in another clinical study of an investigational drug or investigational device or have participated in another clinical study of an investigational drug or investigational device within the past 30 days that would interfere with the interpretation of the study results or the conduct of the study.
• Patients who are judged by the Study Site PI to be unsuitable for the study.
• Patients receiving immunosuppressive therapy for bone marrow or another transplant.
• Patients currently or previously enrolled in this study or the APEX study (JPS-0301).
• Patients who receive therapy including any of the following drugs, which will not be withheld for a period beginning at least one dosing cycle (minimum 7 days) prior to planned surgery and ending at least 14 days following planned surgery: Adalimumab (Humira) Tocilizumab (Actemra) Etenercept (Enbrel) Anakinra (Kineret) Golimumab (Simponi) Secukinimab (Cosentyx) Infliximab (Remicade) Ustekinumab (Stelara) Abatacept (Orencia) Rituximab (Rituxan) Certolizumab (Cimzia) Tofacitinib (Xeljanz) Belimumab (Benlysta).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/21/23. Questions regarding updates should be directed to the study team contact.