Oral Antibiotics After 2-Stage Revision for Infected Total Hip Arthroplasty and Total Knee Arthroplasty
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.
|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 ]
|Study Start Date:||July 2011|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760863
|Contact: Craig J Della Valle, MDfirstname.lastname@example.org|
|United States, Illinois|
|Rush University Medical Center||Recruiting|
|Chicago, Illinois, United States, 60607|
|Contact: Darren R Plummer, MBA 312-432-2468 email@example.com|
|Contact: Craig J Della Valle, MD 312-432-2350 firstname.lastname@example.org|
|Principal Investigator: Craig J Della Valle, MD|
|Central DuPage Hospital||Recruiting|
|Winfield, Illinois, United States, 60190|
|Contact: Scott M Sporer, MD,MS email@example.com|
|Principal Investigator: Scott M Sporer, MD, MS|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Javad Parvizi, MD firstname.lastname@example.org|
|Principal Investigator: Javad Parvizi, MD, FRCS|