CompletedPhase 2

A Second Trial of the Abbreviated Protocol Two-Stage Exchange

United States76 participantsStarted 2023-01-23

Plain-language 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 periprosthetic joint infection (PJI), absence of continued antibiotic 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.

Who can participate

Age range22 Years – 84 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 a medical history or current medical condition that requires a planned prescription of suppressive antibiotics to treat PJI of the index joint for \> 12 months post Stage-2 surgery; * 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…

What they're measuring

Overall Treatment Success

Timeframe: 180 days

Trial details

NCT IDNCT05607030

SponsorOsteal Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-20