Infected Total Hip or Knee ArthroplastyNCT01683734
Assessing Renal Function in Patients With an Antibiotic Laden Spacer
An observational study of Infected Total Hip or Knee Arthroplasty, run by Central DuPage Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infected Total Hip or Knee Arthroplasty
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with an infected hip or knee arthroplasty scheduled to undergo a 2-stage resection surgery
Who may be able to join
- All patients undergoing a hip or knee resection arthroplasty by the primary investigator
- Ages 18+
- Ability to adhere to follow up schedule
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
RUSH University Medical Center
Chicago, Illinois, 60612
- Recruiting
Central DuPage Hospital
Winfield, Illinois, 60190
Scott Sporer, MD
About this study
Official title: Nephrotoxicity Following 2-Stage Exchange With Associated Antibiotic Laden Spacer in Patients With Infected Total Hip/Knee Arthroplasty
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Renal Function Observation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of acute renal insufficiency or acute renal failure measured by changes in laboratory values assessing renal function
Measured: subjects will be followed during the time the antibiotic spacer is in place which is approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infected Total Hip or Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central DuPage Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Sporer, MD, Principal investigator, RUSH University Medical Center; Central DuPage Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683734
- Sponsor's protocol ID
- Nephro11-021-1
- Status last verified
- Feb 2015
- First submitted
- 28 Aug 2012
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nephrotoxicity Following 2-Stage Exchange With Associated Antibiotic Laden Spacer in Patients With Infected Total Hip/Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01683734
- Acronym / sponsor ID
- Nephro11-021-1
- Conditions
- Infected Total Hip or Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Central DuPage HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2019 (estimated)
- First posted
- 12 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal Function Observation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with an infected hip or knee arthroplasty scheduled to undergo a 2-stage resection surgery
Key inclusion criteria (3 listed)
- All patients undergoing a hip or knee resection arthroplasty by the primary investigator
- Ages 18+
- Ability to adhere to follow up schedule
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Sporer, MD principal investigator
RUSH University Medical Center; Central DuPage Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infected Total Hip or Knee Arthroplasty, run by Central DuPage Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefanie Miller, BS (630-933-6254, Stefanie.Miller@CadenceHealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.