Recruiting

Observational Study

Sponsor:

Central DuPage Hospital

Code:

NCT01683734

Conditions

Infected Total Hip or Knee Arthroplasty

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this study is to monitor the renal function of patients who have an antibiotic laden spacer in place to treat an infected hip or knee arthroplasty.

Conditions

Infected Total Hip or Knee Arthroplasty

Study ID

NCT01683734

Start date

May, 2012

Status verified date

Feb, 2015

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. All patients undergoing a hip or knee resection arthroplasty by the primary investigator
2. Ages 18+
3. Ability to adhere to follow up schedule

Exclusion Criteria:

1. Unable to give informed consent
2. Age <18
3. Previous history of infected Total Knee Arthroplasty or Total Hip Arthroplasty
4. History of renal failure or impaired renal function
5. Allergies to aminoglycosides or Vancomycin

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Renal Function Observation

Primary outcome measure

  • Development of acute renal insufficiency or acute renal failure measured by changes in laboratory values assessing renal function [ Time Frame: subjects will be followed during the time the antibiotic spacer is in place which is approximately 8 weeks ]

Central Contacts and Locations

Central contacts

Stefanie Miller, BS

630-933-6254Stefanie.Miller@CadenceHealth.org

Judy Guerreiro, RN

630-933-2941Judy.Guerreiro@CadenceHealth.org

Locations

RUSH University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Central DuPage Hospital

Recruiting

Winfield, Illinois, United States, 60190

Principal Investigator:

Scott Sporer, MD

More Information

Sponsor

Central DuPage Hospital

Last update posted

Feb 4, 2015

Last verified

Feb, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Central DuPage Hospital on 2015-02-04.