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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Rush University Medical Center
Sponsor:
Information provided by (Responsible Party):
Craig J Della Valle, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01760863
First received: January 2, 2013
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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 Intervention
Prosthesis-Related Infections
Other: Oral Antibiotics

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Utility of Oral Antibiotic Therapy Following 2-stage Revision Arthroplasty for Infected Prosthetic Hips and Knees

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Infection Rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2011
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760863

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

Locations
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60607
Contact: Darren R Plummer, MBA    312-432-2468    darren.plummer@rushortho.com   
Contact: Craig J Della Valle, MD    312-432-2350    craigdv@yahoo.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         
Sponsors and Collaborators
Rush University Medical Center
  More Information

Publications:
Responsible Party: Craig J Della Valle, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01760863     History of Changes
Other Study ID Numbers: 11040802
Study First Received: January 2, 2013
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
Revision
Knee
Hip
Arthroplasty
Oral
Antibiotics
Infection

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

ClinicalTrials.gov processed this record on August 26, 2014