Official Title: “Randomised And Double Blind Study To Evaluate The Best Moment To Infuse The Prophylactic Antibiotic In Knee Arthroplasty Performed Under Ischemia”

Knee prosthesis infection is a severe complication. The use of a tourniquet during surgery impairs the efficacy of the antibiotic prophylaxis. We hypothesize that the antibiotic administration before tourniquet release decrease the infection rate. Methods: patients who undergo a total knee arthroplasty will be randomized to receive one of the following regimens of antibiotic prophylaxis:Standard: cefuroxime 1.5 g i.v. 10 min before tourniquet + placebo 10 min before tourniquet release + cefuroxime 1'5 g i.v. 6h after closing surgical wound.Experimental: cefuroxime 1.5 g i.v. 10 min before tourniquet + cefuroxime 1.5 g i.v. 10 min before tourniquet release + cefuroxime 1'5 g i.v. 6h after closing surgical wound.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: August 2010

Objective: when surgery is performed under ischemia, the ideal timing for the administration of antibiotic prophylaxis has not been well defined.

Currently, antibiotics are given 10 minutes before ischemia and the infection rate is about 3-5%. In 2005 we performed a study where the efficacy of the standard prophylaxis was compared with a new regimen that consisted in administering the antibiotic 10 min. before tourniquet release. The results were positive although the difference was not statistically significant. In the present study we are proposing a new protocol where the antibiotic is given 10 min. before the inflation of tourniquet and 10 min. before its release.

Methodology: all patients who undergo a total knee arthroplasty will be randomized to receive one of the following regimens of antibiotic prophylaxis:Standard: cefuroxime 1.5 g i.v. 10 min before tourniquet + placebo 10 min before tourniquet release + cefuroxime 1'5 g i.v. 6h after closing surgical wound.Experimental: cefuroxime 1.5 g i.v. 10 min before tourniquet + cefuroxime 1.5 g i.v. 10 min before tourniquet release + cefuroxime 1'5 g i.v. 6h after closing surgical wound.The infection rate with standard regimen is 3.4%. We believe that the new regimen will decrease the rate of infection to 1%. To demonstrate differences between both arms, it will be necessary to include 666 patients per arm.

Intervention(s) in this Clinical Trial

• Drug: cefuroxime
  • cefuroxime is administered at a dosage of 1.5 g before tourniquet inflation and release in experimental arm and only before tourniquet inflation in control arm
• Drug: placebo
  • cefuroxime 1.5 g IV before tourniquet inflation + placebo before tourniquet release + cefuroxime 1.5 g IV 6 h after surgery

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • antibiotic is given before tourniquet inflation and before tourniquet release
• Placebo Comparator: 2
  • antibiotic is given before tourniquet inflation

Primary Measures

• infection rate
  • Time Frame: 12 months
    Safety Issue?: No

Inclusion Criteria:

• patients undergoing knee arthroplasty

Exclusion Criteria:

• patients allergic to penicillin

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hospital Clinic of Barcelona

Overall Clinical Trial Officials and Contacts

Alex Soriano, MD Principal Investigator Hospital Clínical  

Overall Contact: Alex Soriano, MD 00-34-932275708 asoriano@clinic.ub.es

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00497341

Study ID Number: PTR2007

ClinicalTrials.gov Identifier: NCT00497341

Health Authority: Spain: Ethics Committee