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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2020-09-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Prosthesis-Related Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Oral Antibiotics

Oral antibiotics for 3 months; recommendation for antibiotics will be made by an infectious disease specialist.

Group Type EXPERIMENTAL

Oral Antibiotics

Intervention Type OTHER

Oral Antibiotics will be prescribed for 3 months per recommendations of an infectious disease specialist.

No oral antibiotics

No oral antibiotics.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oral Antibiotics

Oral Antibiotics will be prescribed for 3 months per recommendations of an infectious disease specialist.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No