Articulating Versus Static Antibiotic Loaded Spacers for the Treatment of Prosthetic Knee Infection
Osteoarthritis, Knee Infection, Prosthetic Joint Infection
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring arthroplasty, knee replacement, Osteoarthritis, knee Infection, Prosthetic Joint Infection, Complications; Arthroplasty, Infection or Inflammation, Complications; Arthroplasty
Eligibility Criteria
Inclusion Criteria:
1) Diagnosis of a periprosthetic joint infection of a primary total knee arthroplasty with a planned two-stage exchange procedure.
Exclusion Criteria:
- Infection of a revision as opposed to a primary total knee arthroplasty
- Medically unfit for operative intervention
- Extensive bone loss preventing the use of an articulating spacer
- Soft tissue defects that prevent the use of an articulating spacer
- Known allergy to polymethylmethacrylate, tobramycin or vancomycin.
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Static Spacer
Articulating Spacer
After diagnosis of infection and informed consent, patients will be taken to the operating room. After anesthetization, patients will be randomized to either an articulating spacer or a static spacer. Randomization will be performed by prepared opaque envelopes administered by a nonparticipant in the study. After a complete debridement of devitalized tissue, explantation of the infected components and any associated cement, either an articulating or static spacer will be placed. All spacers will be formed of 3 g of Vancomycin and 1 g of Tobramycin for each 40 g packet of cement. Static spacers will be hand-made to fit the femoral and tibial exposed metaphyses as a solid block with associated antibiotic cement coated tibial and femoral intramedullary rod, such that knee motion will be minimized.
After diagnosis of infection and informed consent, patients will be taken to the operating room. After anesthetization, patients will be randomized to either an articulating spacer or a static spacer. Randomization will be performed by prepared opaque envelopes administered by a nonparticipant in the study. After a complete debridement of devitalized tissue, explantation of the infected components and any associated cement, either an articulating or static spacer will be placed. All spacers will be formed of 3 g of Vancomycin and 1 g of Tobramycin for each 40 g packet of cement. Articulating spacers will be formed of antibiotic impregnated cement using the Stage One system (Biomet, Warsaw, IN).