A Second Trial of the Abbreviated Protocol Two-Stage Exchange

• Status: Not yet recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

Summary

Apex-2 is a multi-site, parallel group, randomized trial. Patients will be randomly assigned in a 1:1 ratio to the Experimental Arm or the Control Arm.

The objective of the study is to evaluate safety and determine efficacy of the VT-X7 system. Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 180 days, consisting of a revision prosthesis implanted at Stage 2, absence of PJI, absence of continued antiobiotic therapy for treatment or prophylaxis of PJI, absence of revision surgery and absence of mortality. Secondary objectives are to evaluate overall success at 365 days, overall safety of the VT-X7 procedure, 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: 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 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 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 (i.e., chronic kidney disease Stage 4 or 5 or patients with an estimated glomerular filtration rate <30 mL/min);

• Patients on chemotherapy for malignant disease;

• Patients on systemic glucocorticoid therapy (prednisone >10 mg/day or equivalent);

• Patients who are immunodeficient (e.g., splenectomy, sickle cell anemia, Stage 3 human immunodeficiency virus 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 or polyurethane;

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

• Patients with a fungal PJI as determined by one or more positive fluid and/or tissue cultures;

• Patients who have a skeletal defect 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 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 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 drug 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 biologic agents, 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)