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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