Oral Antibiotics After 2-Stage Revision for Infected Total Hip Arthroplasty and Total Knee Arthroplasty
The Utility of Oral Antibiotic Therapy Following 2-stage Revision Arthroplasty for Infected Prosthetic Hips and Knees
1 other identifier
interventional
185
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2011
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 2, 2013
CompletedFirst Posted
Study publicly available on registry
January 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2020
CompletedAugust 25, 2021
August 1, 2021
9.1 years
January 2, 2013
August 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infection Rate
24 months
Study Arms (2)
Oral Antibiotics
EXPERIMENTALOral antibiotics for 3 months; recommendation for antibiotics will be made by an infectious disease specialist.
No oral antibiotics
NO INTERVENTIONNo oral antibiotics.
Interventions
Oral Antibiotics will be prescribed for 3 months per recommendations of an infectious disease specialist.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Rush University Medical Center
Chicago, Illinois, 60607, United States
Central DuPage Hospital
Winfield, Illinois, 60190, United States
Rothman Institute
Philadelphia, Pennsylvania, 19107, United States
Vanderbilt
Nashville, Tennessee, 37232, United States
Related Publications (1)
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.
PMID: 20213514RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 2, 2013
First Posted
January 4, 2013
Study Start
July 1, 2011
Primary Completion
August 1, 2020
Study Completion
September 23, 2020
Last Updated
August 25, 2021
Record last verified: 2021-08