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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01631968
Enrollment
2948
Registered
2012-06-29
Start date
2007-09-30
Completion date
2012-05-31
Last updated
2016-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection After Primary Total Knee Arthroplasty

Brief summary

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.

Interventions

PROCEDURECement without antibiotic.
PROCEDURECement with erytromycin and colistin.

Sponsors

Parc de Salut Mar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Primary total knee replacement. Both genders. No age limits.

Exclusion criteria

* Allergy to erythromycin or colistin. Previous infection in the knee.

Design outcomes

Primary

MeasureTime frameDescription
InfectionThe 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026