Articulating Versus Static Antibiotic Loaded Spacers for the Treatment of Prosthetic Knee Infection

NACompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

August 31, 2020

Study Completion Date

August 31, 2020

Conditions
OsteoarthritisKnee InfectionProsthetic Joint InfectionComplications; Arthroplasty, Infection or InflammationComplications; Arthroplasty
Interventions
PROCEDURE

Static 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.

PROCEDURE

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. Articulating spacers will be formed of antibiotic impregnated cement using the Stage One system (Biomet, Warsaw, IN).

Trial Locations (1)

60612

Rush University Medical Center, Chicago

All Listed Sponsors
collaborator

Central DuPage Hospital

OTHER

collaborator

Joint Implant Surgeons, Inc.

OTHER

collaborator

Thomas Jefferson University

OTHER

lead

Rush University Medical Center

OTHER

NCT01373112 - Articulating Versus Static Antibiotic Loaded Spacers for the Treatment of Prosthetic Knee Infection | Biotech Hunter | Biotech Hunter