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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01760863
Recruitment Status : Recruiting
First Posted : January 4, 2013
Last Update Posted : March 10, 2017
Information provided by (Responsible Party):

Study Description
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
Prosthesis-Related Infections Other: Oral Antibiotics

Study Design

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :
  1. Infection Rate [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760863

Contact: Craig J Della Valle, MD 3124322350 craigdv@yahoo.com

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

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    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017

Keywords provided by Craig J Della Valle, Rush University Medical Center:

Additional relevant MeSH terms:
Prosthesis-Related Infections
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents