Oral Antibiotics After 2-Stage Revision for Infected Total Hip Arthroplasty and Total Knee Arthroplasty
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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 |
- 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 |
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| United States, Illinois | |
| Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60607 | |
| Contact: Paul H Yi, BA 312-432-2468 paul.yi@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 | |
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: | January 3, 2013 |
| 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 Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013