NCT00497341

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,332

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

2.6 years

First QC Date

July 5, 2007

Last Update Submit

February 17, 2016

Conditions

Infection

Keywords

infection after total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • infection rate

    12 months

Study Arms (2)

1

EXPERIMENTAL

antibiotic is given before tourniquet inflation and before tourniquet release

Drug: cefuroxime

2

PLACEBO COMPARATOR

antibiotic is given before tourniquet inflation

Drug: placebo

Interventions

cefuroximeDRUG

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

1
placeboDRUG

cefuroxime 1.5 g IV before tourniquet inflation + placebo before tourniquet release + cefuroxime 1.5 g IV 6 h after surgery

2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing knee arthroplasty

You may not qualify if:

  • patients allergic to penicillin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic

Barcelona, Catalonia, 08036, Spain

Location

MeSH Terms

Conditions

Infections

Interventions

Cefuroxime

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Alex Soriano, MD

    Hospital Clínical

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant of infectious diseases

Study Record Dates

First Submitted

July 5, 2007

First Posted

July 6, 2007

Study Start

January 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

February 19, 2016

Record last verified: 2016-02

Locations

ES(1)