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First received: October 31, 2022

Clinical Trial: A Second Trial of the Abbreviated Protocol Two-Stage Exchange

Study Status: Completed

Recruit Status: RECRUITING

Condition: Prosthetic-joint Infection

Study Type: INTERVENTIONAL


Official Title: A Second Randomized Controlled Trial of Alternating Irrigation of Vancomycin Hydrochloride and Tobramycin Sulfate in Patients Undergoing Two-Stage Exchange Arthroplasty for Periprosthetic Joint Infect

Brief 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…

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