Assessing Renal Function in Patients With an Antibiotic Laden Spacer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Central DuPage Hospital
Information provided by (Responsible Party):
Central DuPage Hospital Identifier:
First received: August 28, 2012
Last updated: February 3, 2015
Last verified: February 2015
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.

Infected Total Hip or Knee Arthroplasty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nephrotoxicity Following 2-Stage Exchange With Associated Antibiotic Laden Spacer in Patients With Infected Total Hip/Knee Arthroplasty

Resource links provided by NLM:

Further study details as provided by Central DuPage Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Renal Function Observation


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with an infected hip or knee arthroplasty scheduled to undergo a 2-stage resection surgery

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01683734

Contact: Stefanie Miller, BS 630-933-6254
Contact: Judy Guerreiro, RN 630-933-2941

United States, Illinois
RUSH University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Central DuPage Hospital Recruiting
Winfield, Illinois, United States, 60190
Principal Investigator: Scott Sporer, MD         
Sponsors and Collaborators
Central DuPage Hospital
Principal Investigator: Scott Sporer, MD RUSH University Medical Center; Central DuPage Hospital
  More Information

No publications provided

Responsible Party: Central DuPage Hospital Identifier: NCT01683734     History of Changes
Other Study ID Numbers: Nephro11-021-1
Study First Received: August 28, 2012
Last Updated: February 3, 2015
Health Authority: United States: Food and Drug Administration processed this record on November 25, 2015