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

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Rush

Status

Completed

Conditions

Prosthesis-Related Infections

Treatments

Other: Oral Antibiotics

Study type

Interventional

Funder types

Other

Identifiers

NCT01760863
11040802

Details and patient eligibility

About

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.

Enrollment

185 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

185 participants in 2 patient groups

Oral Antibiotics
Experimental group
Description:
Oral antibiotics for 3 months; recommendation for antibiotics will be made by an infectious disease specialist.
Treatment:
Other: Oral Antibiotics
No oral antibiotics
No Intervention group
Description:
No oral antibiotics.

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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