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Prophylaxis of Periprosthetic Joint Infections With Calcium Sulfate Beads in Patients With Non-modifiable Risk Factors.

NCT03976466 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2020-08-20

Study results available
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Summary

To demonstrate the prophylactic effect of calcium sulfate beads loaded with antibiotic in patients with non-modifiable risk factors that will undergo a hip or knee joint replacement, comparing with a control group.

To know the economic cost generated in antibiotic prophylaxis with calcium sulfate beads in patients undergoing hip or knee joint replacement with non-modifiable risk factors.

Conditions

Interventions

DEVICE

Antibiotic local prophylaxis with medicated calcium sulfate beads

Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection

PROCEDURE

Classical parenteral antibiotic prophylaxis

Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection

Sponsors & Collaborators

  • Hospital Regional Tlalnepantla

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-22
Primary Completion
2020-04-22
Completion
2020-07-15

Countries

  • Mexico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03976466 on ClinicalTrials.gov