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

Primary Purpose

Prosthesis-Related Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral Antibiotics
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prosthesis-Related Infections focused on measuring Revision, Knee, Hip, Arthroplasty, Oral, Antibiotics, Infection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rush University Medical Center
  • Central DuPage Hospital
  • Rothman Institute
  • Vanderbilt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oral Antibiotics

No oral antibiotics

Arm Description

Oral antibiotics for 3 months; recommendation for antibiotics will be made by an infectious disease specialist.

No oral antibiotics.

Outcomes

Primary Outcome Measures

Infection Rate

Secondary Outcome Measures

Full Information

First Posted
January 2, 2013
Last Updated
August 19, 2021
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01760863
Brief Title
Oral Antibiotics After 2-Stage Revision for Infected Total Hip Arthroplasty and Total Knee Arthroplasty
Official Title
The Utility of Oral Antibiotic Therapy Following 2-stage Revision Arthroplasty for Infected Prosthetic Hips and Knees
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 2011 (Actual)
Primary Completion Date
August 2020 (Actual)
Study Completion Date
September 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis-Related Infections
Keywords
Revision, Knee, Hip, Arthroplasty, Oral, Antibiotics, Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Antibiotics
Arm Type
Experimental
Arm Description
Oral antibiotics for 3 months; recommendation for antibiotics will be made by an infectious disease specialist.
Arm Title
No oral antibiotics
Arm Type
No Intervention
Arm Description
No oral antibiotics.
Intervention Type
Other
Intervention Name(s)
Oral Antibiotics
Intervention Description
Oral Antibiotics will be prescribed for 3 months per recommendations of an infectious disease specialist.
Primary Outcome Measure Information:
Title
Infection Rate
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Central DuPage Hospital
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20213514
Citation
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.
Results Reference
result

Learn more about this trial

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

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