Clinical trial NCT01079559: The Effectiveness of Antibiotic Cement (ABC) Compared to Regular Cement in Reducing the Rate of Infection Following Total Knee Arthroplasty: The ABC Trial
Official title: The Effectiveness of Antibiotic Cement Compared to Regular Cement in Reducing the Rate of Infection Following Total Knee Arthroplasty: The ABC Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Infection
Osteoarthritis of the Knee
Keywords: total knee arthroplasty
infection
antibiotic bone cement
Lead sponsor: University of Western Ontario, Canada
Sponsor class: OTHER
First posted: 2010-03-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: relative risk of infection
timeFrame: 6 weeks and 3, 12 and 24 months postoperative
Secondary outcomes:
measure: radiographic evidence of prosthetic failure
timeFrame: 6 weeks and 3, 12 and 24 months postoperative
measure: patient-reported disease-specific health-related quality of life (HRQOL)
timeFrame: 6 weeks and 3, 12 and 24 months postoperative
measure: cost-effectiveness
timeFrame: 6 weeks and 3, 12 and 24 months postoperative
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre, University Hospital
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Dianne Bryant, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western University, Canada
name: Steven J MacDonald, MD
role: PRINCIPAL_INVESTIGATOR
References: