Oral Antibiotics After 2-Stage Revision for Infected Total Hip Arthroplasty and Total Knee Arthroplasty

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Prosthesis-Related Infections	Other: Oral Antibiotics	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	The Utility of Oral Antibiotic Therapy Following 2-stage Revision Arthroplasty for Infected Prosthetic Hips and Knees
Study Start Date :	July 2011
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	December 2020

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Infection Rate [ Time Frame: 24 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: Craig Della Valle, MD 312-432-2468 dellavalle.research@rushortho.com
Contact: Chris Culvern 312-432-2470 chris.culvern@rushortho.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
United States, Tennessee
Vanderbilt	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Gregory Polkowski, MD, MPH gregorypolkowski@vanderbilt.edu
Contact: Julie Daniels 615-322-4506 julie.m.daniels@vanderbilt.edu

Sponsors and Collaborators

Rush University Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Zywiel MG, Johnson AJ, Stroh DA, Martin J, Marker DR, Mont MA. Prophylactic oral antibiotics reduce reinfection rates following two-stage revision total knee arthroplasty. Int Orthop. 2011 Jan;35(1):37-42. doi: 10.1007/s00264-010-0992-x. Epub 2010 Mar 7.

Responsible Party:	Craig J Della Valle, MD, Rush University Medical Center
ClinicalTrials.gov Identifier:	NCT01760863 History of Changes
Other Study ID Numbers:	11040802
First Posted:	January 4, 2013
Last Update Posted:	March 10, 2017
Last Verified:	March 2017

Keywords provided by Craig J Della Valle, 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