Assessing Renal Function in Patients With an Antibiotic Laden Spacer
Nephrotoxicity Following 2-Stage Exchange With Associated Antibiotic Laden Spacer in Patients With Infected Total Hip/Knee Arthroplasty
1 other identifier
observational
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 28, 2012
CompletedFirst Posted
Study publicly available on registry
September 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedFebruary 4, 2015
February 1, 2015
7.6 years
August 28, 2012
February 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Development of acute renal insufficiency or acute renal failure measured by changes in laboratory values assessing renal function
subjects will be followed during the time the antibiotic spacer is in place which is approximately 8 weeks
Study Arms (1)
Renal Function Observation
Eligibility Criteria
patients with an infected hip or knee arthroplasty scheduled to undergo a 2-stage resection surgery
You may qualify if:
- All patients undergoing a hip or knee resection arthroplasty by the primary investigator
- Ages 18+
- Ability to adhere to follow up schedule
You may not qualify if:
- Unable to give informed consent
- Age \<18
- Previous history of infected Total Knee Arthroplasty or Total Hip Arthroplasty
- History of renal failure or impaired renal function
- Allergies to aminoglycosides or Vancomycin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
RUSH University Medical Center
Chicago, Illinois, 60612, United States
Central DuPage Hospital
Winfield, Illinois, 60190, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Sporer, MD
RUSH University Medical Center; Central DuPage Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2012
First Posted
September 12, 2012
Study Start
May 1, 2012
Primary Completion
December 1, 2019
Last Updated
February 4, 2015
Record last verified: 2015-02