NCT01631968

Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement

Completed NA Last updated 23 February 2016

What this trial tests

NA trial testing Cement without antibiotic. in Infection After Primary Total Knee Arthroplasty in 2,948 participants. Completed in 1 May 2012.

Timeline

1 September 2007

Primary endpoint
1 March 2011

1 May 2012

Quick facts

Lead sponsor	Parc de Salut Mar
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	2,948
Start date	1 September 2007
Primary completion	1 March 2011
Estimated completion	1 May 2012
Sites	1 location across Spain

Drugs / interventions tested

• Cement without antibiotic.
• Cement with erytromycin and colistin.

Conditions studied

• Infection After Primary Total Knee Arthroplasty — all drugs for Infection After Primary Total Knee Arthroplasty →

Sponsor

Parc de Salut Mar — full company profile →

Who can join

18 and older, any sex, with Infection After Primary Total Knee Arthroplasty. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Infection
  Time frame: The minimum follow-up is 12 months.
  Presence or absence of infection, according to the Center for Disease Control's criteria. The infection cases are classified as superficial of deep infection.

Sponsor's own description

Prospective randomized study in cemented primary total knee arthroplasty. In one group the cement used was standard cement, without any antibiotics and in the other group the cement used was loaded with 0.5 g of erythromycin and 3 million units of colistin in 40 g of cement. In all cases intravenous antibiotics prophylaxis against infection was used. In both groups the cement was mechanically mixed in a vacuum. One deep drain tube was placed for 24 hours in all cases. The main variable was the presence of infection according to the Center of Disease Control criteria with a minimum of 12 months follow-up.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Incidence, functional outcomes and cure rate of hematogenous infection in a 2,498 Total Knee Arthroplasties cohort.
   Pérez-Prieto D, Pardo A, Fontanellas A, Gómez-Junyent J, et al · · 2023 · cited 1× · PMID 37743403 · DOI 10.1186/s40634-023-00656-2