Trials / Completed
CompletedNCT01631968
Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,948 (actual)
- Sponsor
- Parc de Salut Mar · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Cement without antibiotic. | |
| PROCEDURE | Cement with erytromycin and colistin. |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2011-03-01
- Completion
- 2012-05-01
- First posted
- 2012-06-29
- Last updated
- 2016-02-24
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT01631968. Inclusion in this directory is not an endorsement.