Last updated on July 2019

Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation


Brief description of study

Study Type

Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial.

Primary Study Objective

The objective of the study is to determine the safety profile of local antibiotic irrigation for the treatment of PJI.

Primary Outcome Measure

The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions.

Follow-up

Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 12 months from initial surgery.

Clinical Study Identifier: NCT03721328

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Ortho Indy

Indianapolis, IN United States
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