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

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ClinicalTrials.gov Identifier: NCT01760863
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : August 25, 2021
Information provided by (Responsible Party):
Craig J Della Valle, MD, Rush University Medical Center

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 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
Actual Study Start Date : July 2011
Actual Primary Completion Date : August 2020
Actual Study Completion Date : September 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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.

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

Information from the National Library of Medicine

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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.

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

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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60607
Central DuPage Hospital
Winfield, Illinois, United States, 60190
United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Rush University Medical Center
Publications of Results:
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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: August 25, 2021
Last Verified: August 2021
Keywords provided by Craig J Della Valle, MD, Rush University Medical Center:
Additional relevant MeSH terms:
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Prosthesis-Related Infections
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents