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

NCT ID: NCT01631968

Last Updated: 2016-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2948 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infection After Primary Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cement with erytromycin and colistin

In this group the knee arthroplasty was fixed with cement with erythromycin and colistin.

Group Type EXPERIMENTAL

Cement with erytromycin and colistin.

Intervention Type PROCEDURE

Cement without antibiotic

In this group the knee arthroplasty was fixed with standard cement, without any antibiotics.

Group Type PLACEBO_COMPARATOR

Cement without antibiotic.

Intervention Type PROCEDURE

Interventions

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Cement without antibiotic.

Intervention Type PROCEDURE

Cement with erytromycin and colistin.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parc de Salut Mar

OTHER

Sponsor Role lead

Responsible Party

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Pedro Hinarejos

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital de la Esperanza.

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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Hinarejos P, Guirro P, Leal J, Montserrat F, Pelfort X, Sorli ML, Horcajada JP, Puig L. The use of erythromycin and colistin-loaded cement in total knee arthroplasty does not reduce the incidence of infection: a prospective randomized study in 3000 knees. J Bone Joint Surg Am. 2013 May 1;95(9):769-74. doi: 10.2106/JBJS.L.00901.

Reference Type DERIVED
PMID: 23636182 (View on PubMed)

Other Identifiers

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ERITR-COL

Identifier Type: -

Identifier Source: org_study_id

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