Oral Antibiotics After 2-Stage Revision for Infected Total Hip Arthroplasty and Total Knee Arthroplasty
This study is currently recruiting participants.
(see Contacts and Locations)
Verified April 2016 by Rush University Medical Center
Sponsor:
Rush University Medical Center
Information provided by (Responsible Party):
Craig J Della Valle, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01760863
First received: January 2, 2013
Last updated: April 14, 2016
Last verified: April 2016
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Purpose
The primary purpose of this study is to compare the re-infection rates in patients undergoing 2-stage revision arthroplasty who receive additional oral antibiotic therapy to those patients who received in-hospital perioperative antibiotic only. Patients will be monitored for re-infection following hospital discharge, defined as deep infection of the joint space/capsule that requires return to the operating room within 24-months of the re-implantation procedure.
| Condition | Intervention |
|---|---|
|
Prosthesis-Related Infections |
Other: Oral Antibiotics |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | The Utility of Oral Antibiotic Therapy Following 2-stage Revision Arthroplasty for Infected Prosthetic Hips and Knees |
Resource links provided by NLM:
Further study details as provided by Rush University Medical Center:
Primary Outcome Measures:
- Infection Rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2011 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Oral Antibiotics
Oral antibiotics for 3 months; recommendation for antibiotics will be made by an infectious disease specialist.
|
Other: Oral Antibiotics
Oral Antibiotics will be prescribed for 3 months per recommendations of an infectious disease specialist.
|
|
No Intervention: No oral antibiotics
No oral antibiotics.
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
Adult patients undergoing 2-stage revision arthroplasty of the knee or hip with the causative organism(s) identified using tissue culture and/or joint fluid analysis that is amenable to oral antibiotic therapy. Patients must be able to tolerate oral antibiotics and agree to participate in the study.
Exclusion criteria:
Patients with a fungal prosthetic joint infection, unable to tolerate or refuse to undergo oral antibiotic therapy, unable to follow-up at the specified intervals, allergic to the therapy of preference, or have an organism that is not amenable to oral antibiotic therapy.
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 ClinicalTrials.gov identifier: NCT01760863
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760863
Contacts
| Contact: Craig J Della Valle, MD | 3124322350 | craigdv@yahoo.com |
Locations
| United States, Illinois | |
| Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60607 | |
| Contact: Darren R Plummer, MBA 312-432-2468 darren.plummer@rushortho.com | |
| Contact: Craig J Della Valle, MD 312-432-2350 craigdv@yahoo.com | |
| Principal Investigator: Craig J Della Valle, MD | |
| Central DuPage Hospital | Recruiting |
| Winfield, Illinois, United States, 60190 | |
| Contact: Scott M Sporer, MD,MS scott.sporer@rushortho.com | |
| Principal Investigator: Scott M Sporer, MD, MS | |
| United States, Pennsylvania | |
| Rothman Institute | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Javad Parvizi, MD parvj@aol.com | |
| Principal Investigator: Javad Parvizi, MD, FRCS | |
Sponsors and Collaborators
Rush University Medical Center
More Information
Publications:
| Responsible Party: | Craig J Della Valle, MD, Rush University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01760863 History of Changes |
| Other Study ID Numbers: | 11040802 |
| Study First Received: | January 2, 2013 |
| Last Updated: | April 14, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Rush University Medical Center:
|
Revision Knee Hip Arthroplasty |
Oral Antibiotics Infection |
Additional relevant MeSH terms:
|
Prosthesis-Related Infections Infection Postoperative Complications Pathologic Processes |
Anti-Bacterial Agents Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents |
ClinicalTrials.gov processed this record on September 23, 2016