Abbreviated Protocol for Two-Stage Exchange

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Study Type: A multi-site, parallel group, randomized trial.

Study Objectives: The objective is to evaluate safety and determine preliminary efficacy of VT-X7. Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 90 days, consisting of a revision prosthesis implanted at Stage 2, patient survival, absence of reoperation and absence of PJI. Secondary objectives are to evaluate superiority at 365 days in a composite endpoint of Overall Success, and in separate secondary endpoints for quality of life (QoL) and patient survival. The exploratory objective is to compare Experimental and Control Arms in exploratory endpoints.

Follow-up: Patients will be evaluated at 90-, 180-, and 365-day follow-up visits.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joint Purification Systems; Osteal Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Scheduled for two-stage exchange arthroplasty due to hip or knee 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 one-stage or two-stage exchange arthroplasties of the infected joint;

• Patients with acute PJI, defined as total joint arthroplasty surgery within 4 weeks prior to enrollment (Stage 1) in this study;

• Patients with bacteremia or positive bacterial blood culture in the last 6 months;

• Patients with concurrent PJI of more than one joint;

• Patients with ongoing active infection of an intravenous (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 (chronic kidney disease (CKD) Stage 4 or greater or glomerular filtration rate (GFR) <30 mL/min);

• Patients on chemotherapy for malignant disease;

• Patients on systemic glucocorticoid therapy (prednisone >5 mg/day or equivalent);

• Patients with immunodeficiency (e.g., splenectomy, sickle cell anemia, Stage 3 human immunodeficiency virus (HIV) infection, primary humoral immunodeficiency, or bone marrow or other transplantation);

• Patients who have an allergy to vancomycin HCl 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 or polyurethane.

• Patients who are pregnant or planning to become pregnant in the next 12 months;

• Patients in whom NPWT is contraindicated;

• Patients with a PJI pathogen that is not considered susceptible to vancomycin HCl or tobramycin sulfate, per the Principal Investigator's (PI's) opinion, including fungal infection;

• Patients who have a "megaprosthesis" addressing a large skeletal defect in 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 at the screening visit;

• Patients who are incarcerated or are facing impending incarceration;

• Patients who are currently abusing drugs or alcohol or have been in treatment for substance abuse within the past year;

• 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;

• Patients who have participated in another clinical study of another investigational drug or investigational device within the past 30 days;

• Patients who are judged by the PI to be unsuitable for the study.