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

Phase 3

Withdrawn

• Conditions: Osteoarthritis of the Knee; Infection
• Interventions: Device: Simplex™ P; Device: Simplex™ P with Tobramycin

• Registration Number: NCT01079559
• Lead Sponsor: University of Western Ontario, Canada

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-03
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simplex™ P	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.
Simplex™ P with Tobramycin	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.

Primary Outcome Measures

Name	Time	Method
relative risk of infection	6 weeks and 3, 12 and 24 months postoperative	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

Name	Time	Method
patient-reported disease-specific health-related quality of life (HRQOL)	6 weeks and 3, 12 and 24 months postoperative
cost-effectiveness	6 weeks and 3, 12 and 24 months postoperative
radiographic evidence of prosthetic failure	6 weeks and 3, 12 and 24 months postoperative

Trial Locations

Locations (1)

London Health Sciences Centre, University Hospital; 🇨🇦 London, Ontario, Canada