The Effectiveness of Antibiotic Cement (ABC) Compared to Regular Cement in Reducing the Rate of Infection Following Total Knee Arthroplasty: The ABC Trial
The Effectiveness of Antibiotic Cement (ABC) Compared to Regular Cement in Reducing the Rate of Infection Following Total Knee Arthroplasty: The ABC Trial
Rationale: Infection following total knee replacement (TKA) is a devastating complication
 that usually requires prosthesis removal, hospitalization while the infection is eradicated,
 and a second surgery to implant a revision prosthesis. For primary TKA, prophylactic
 antibiotic-loaded cement (ABC) may not only reduce the rate of infection it may also reduce
 the rate of revisions due to implant loosening. Current controversy about the use of ABC
 exists around the world. Without a definitive trial, patients will be exposed to a treatment
 of uncertain efficacy that may cause antibiotic resistant bacterial strains and will
 certainly generate high costs to the healthcare system. Purpose: To determine, 1) the extent
 to which ABC compared to regular cement reduces the infection rate in patients over the first
 two years following TKA and, 2) the resource use implications associated with the use of ABC
 for TKA. Methods: This is a randomized clinical trial in which 8,800 patients with undergoing
 primary TKA are allocated to either Simplex™ P with Tobramycin or Simplex™ P bone cement. We
 will exclude patients with a prior joint infection, an allergy to tobramycin, and those with
 no fixed address. All patients will be administered IV antibiotics immediately prior to
 surgery. Patients and surgeons will be blind to group allocation. The primary outcome measure
 is infection. Follow-up visits will take place at 6 weeks and 3, 12 and 24 months
 postoperative. A blinded adjudicator will review all reported infections and determine
 whether the putative infection is a study event. Blinded radiologists will interpret the 2
 year series of radiographs for each patient. We will compare the rates of infection and
 implant loosening between the two treatment groups using survival analyses. This study
 includes a full economic analysis.
Inclusion Criteria:

 -  patients with osteoarthritis of the knee,

 -  patients who are undergoing primary knee replacement,

 -  patients who are able to provide informed consent.

 Exclusion Criteria:

 -  patients with a prior joint infection,

 -  patients who have a known allergy to tobramycin, and

 -  patients who have no fixed address.