The Effectiveness of Antibiotic Cement (ABC) Compared to Regular Cement in Reducing the Rate of Infection Following Total Knee Arthroplasty: The ABC Trial

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Dianne Bryant, University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT01079559
First received: March 1, 2010
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Infection
Osteoarthritis of the Knee
Device: Simplex™ P with Tobramycin
Device: Simplex™ P
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University of Western Ontario, Canada:

Primary Outcome Measures:
  • relative risk of infection [ Time Frame: 6 weeks and 3, 12 and 24 months postoperative ] [ Designated as safety issue: Yes ]
    patients suspected of having an infected total knee replacement in the post-operative period will be evaluated clinically, and will undergo lab evaluation and an aspiration


Secondary Outcome Measures:
  • radiographic evidence of prosthetic failure [ Time Frame: 6 weeks and 3, 12 and 24 months postoperative ] [ Designated as safety issue: Yes ]
  • patient-reported disease-specific health-related quality of life (HRQOL) [ Time Frame: 6 weeks and 3, 12 and 24 months postoperative ] [ Designated as safety issue: No ]
  • cost-effectiveness [ Time Frame: 6 weeks and 3, 12 and 24 months postoperative ] [ Designated as safety issue: No ]

Enrollment: 0
Arms Assigned Interventions
Active Comparator: Simplex™ P
All patients will receive preoperative antibiotics administered within the hour prior to surgery. All patients will undergo a cemented total knee replacement (both femoral and tibial components) with the type of implant left to the discretion of the surgeon. The patella may or may not be resurfaced depending on indication and preference. All patients will receive one of the two study cements (Simplex™ P with Tobramycin or Simplex™ P) in a blinded fashion; all cement vials will be similar in size and shape and the cement will be similar in odour, color and texture. No additional antibiotics will be added to the cement. Surgeons can use their preferred cement preparation technique (i.e. manual or vacuum mixing). The use of a suction drain will depend on surgical indication and preference.
Device: Simplex™ P
All patients will receive preoperative antibiotics administered within the hour prior to surgery.All patients will undergo a cemented total knee replacement (both femoral and tibial components) with the type of implant left to the discretion of the surgeon. The patella may or may not be resurfaced depending on indication and preference. All patients will receive one of the two study cements (Simplex™ P with Tobramycin or Simplex™ P) in a blinded fashion; all cement vials will be similar in size and shape and the cement will be similar in odour, color and texture. No additional antibiotics will be added to the cement. Surgeons can use their preferred cement preparation technique (i.e. manual or vacuum mixing). The use of a suction drain will depend on surgical indication and preference.
Experimental: Simplex™ P with Tobramycin
All patients will receive preoperative antibiotics administered within the hour prior to surgery.All patients will undergo a cemented total knee replacement (both femoral and tibial components) with the type of implant left to the discretion of the surgeon. The patella may or may not be resurfaced depending on indication and preference. All patients will receive one of the two study cements (Simplex™ P with Tobramycin or Simplex™ P) in a blinded fashion; all cement vials will be similar in size and shape and the cement will be similar in odour, color and texture. No additional antibiotics will be added to the cement. Surgeons can use their preferred cement preparation technique (i.e. manual or vacuum mixing). The use of a suction drain will depend on surgical indication and preference.
Device: Simplex™ P with Tobramycin
All patients will receive preoperative antibiotics administered within the hour prior to surgery.All patients will undergo a cemented total knee replacement (both femoral and tibial components) with the type of implant left to the discretion of the surgeon. The patella may or may not be resurfaced depending on indication and preference. All patients will receive one of the two study cements (Simplex™ P with Tobramycin or Simplex™ P) in a blinded fashion; all cement vials will be similar in size and shape and the cement will be similar in odour, color and texture. No additional antibiotics will be added to the cement. Surgeons can use their preferred cement preparation technique (i.e. manual or vacuum mixing). The use of a suction drain will depend on surgical indication and preference.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079559

Locations
Canada, Ontario
London Health Sciences Centre, University Hospital
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
University of Western Ontario, Canada
Investigators
Principal Investigator: Dianne Bryant, PhD University of Western Ontario, Canada
Principal Investigator: Steven J MacDonald, MD University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Dianne Bryant, Associate Professor, University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT01079559     History of Changes
Other Study ID Numbers: CIHR-2010-222495
Study First Received: March 1, 2010
Last Updated: February 6, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of Western Ontario, Canada:
total knee arthroplasty
infection
antibiotic bone cement

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Bacterial Agents
Tobramycin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 24, 2014