Oral Antibiotics After 2-Stage Revision for Infected Total Hip Arthroplasty and Total Knee Arthroplasty
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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 : April 23, 2019
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Condition or disease | Intervention/treatment | Phase |
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Prosthesis-Related Infections | Other: Oral Antibiotics | Not Applicable |
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 2021 |
Estimated Study Completion Date : | December 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Oral Antibiotics
Oral antibiotics for 3 months; recommendation for antibiotics will be made by an infectious disease specialist.
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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.
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- Infection Rate [ Time Frame: 24 months ]

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
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.

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 |
Responsible Party: | Craig J Della Valle, MD, MD, Rush University Medical Center |
ClinicalTrials.gov Identifier: | NCT01760863 |
Other Study ID Numbers: |
11040802 |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | April 23, 2019 |
Last Verified: | April 2019 |
Revision Knee Hip Arthroplasty |
Oral Antibiotics Infection |
Prosthesis-Related Infections Infection Postoperative Complications |
Pathologic Processes Anti-Bacterial Agents Anti-Infective Agents |