Last updated on March 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 primary outcome measure is the number of successful subjects. A successful subject is defined as a subject who achieves ALL of the following qualitative criteria in a composite endpoint.

To be considered a success, patients must achieve ALL of the following components of the composite endpoint after 6 weeks of antibiotic treatment and a 2-week antibiotic holiday:

  • Have a permanent revision prosthesis implanted by 12 weeks post initial surgery; Yes or No AND
  • Have the same functioning prosthesis at 12 weeks post initial surgery; Yes or No AND
  • Show no signs of infection, per the Delphi Criteria, between implantation and 12 weeks post initial surgery Yes or No AND
  • Have no surgical intervention for infection between initial surgery and 12 weeks post initial surgery. Yes or No

Delphi Criteria: (1) infection eradication, characterized by a healed wound without fistula, drainage, or pain, and no infection recurrence caused by the same organism strain; (2) no subsequent surgical intervention after reimplantation surgery owing to infection; and (3) no occurrence of PJI-related mortality (by causes such as sepsis, necrotizing fasciitis.

Follow-up Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 1 year from initial surgery.

Clinical Study Identifier: NCT03721328

Contact Investigators or Research Sites near you

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Ortho Indy

Indianapolis, IN United States
6.11miles
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Recruitment Status: Open


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